Question 4: Columbia University expresses its support for the NIH Public Access Policy, and most experiences at Columbia with implementation have been favorable. Because of the many comments submitted to NIH from other interested parties, we would like to emphasize one particular point: We have found that the policy has yielded some unexpected and important benefits, in addition to the intended consequences of the policy for the public interest.

First, inside the university, implementation of the policy has created an opportunity for several offices and many scientists to work together to address an important development in the law and to devise new policies and procedures that may ultimately increase accessibility of research results. The effort has been an important occasion to review existing positions on related matters and to share ideas within the university on critical issues related to research, publishing, and funding.

Most notably, implementation at Columbia has involved a cooperative interaction among many diverse offices, such as the University Library, the Office of Research Administration, the Office of Research Compliance and Training, the Office of General Counsel, and the Copyright Advisory Office, as well as a many research programs and academic disciplines. One outcome of the process has been a website specifically developed to guide faculty members and others seeking to comply with the NIH policy (http://scholcomm.columbia.edu/nih-public-access-policy/). The website includes explanations of the law and tools and documents for compliance.

Second, we are seeing numerous examples of publishers revising their policies and often implementing standards that are supportive of the public interest beyond the requirements of the law. Scientists at Columbia have appreciated those publishers that have offered to undertake the submission procedures, and those publishers that have chosen to make their works available in final form or on an earlier schedule.

These unexpected benefits of the NIH policy underscore the policy’s fundamental importance to the creation and dissemination of research results. The NIH policy is much more than legal mechanics; it is proving to be an invaluable motivation for universities, scientists, government agencies, and publishers to reevaluate their polices and to implement standards that can more effectively reflect the public interest and the needs of diverse stakeholders. Thank you for this opportunity to submit comments.

05/31/2008 at 03:01:06 PM

Newcomb

Douglas

Master of Science

Special Libraries Association

Alexandria

VA

USA

Other

Question 1: The Special Libraries Association (SLA) appreciates the manner in which the NIH has consistently and willingly engaged its stakeholders in an open and transparent fashion. Independently, and as one of several national library organizations acting in unison, SLA has repeatedly expressed support for open public access to the results of research funded by the NIH and will continue to do so. SLA supports the NIH Public Access Policy in general and its implementation as currently articulated. This policy is a significant opportunity for researchers to expand access to NIH-funded research, and to use and build upon this information in unprecedented ways. The policy will promote new discoveries, help to stimulate innovation, and accelerate the pace of research in general.

One recommendation SLA would make to improve the policy is to shorten the embargo period to six months. A shorter embargo period would more accurately reflect the pace of research and discovery within the biomedical field, and at the same time align the NIH policy with those in around the world, such as Canada, the European Union. A six-month embargo is supported by the increasing adoption of author addenda, which enables authors to retain rights to their work while providing the publisher the license to publish. In our highly competitive global economy, a shortened embargo is an important component to ensure that U.S. policy keeps our research institutions competitive with rest of world.

Question 2: It would be usefull to have the NIH produce a list of publishers whose author publishing agreements provide for deposit with PMC in a manner that is consistent with copyright law.

Question 4: On a note of concern, SLA is aware of a proposal for an alternative implementation of the Public Access

Policy, where NIH would act as a dark archive and provide links to publishers' Web sites. SLA strongly opposes this proposal as it would NOT achieve a major goal of the NIH, which is to provide a permanent, stable archive of its research. To effectively curate a database, and for the quality of material it contains to be preserved, it must be used regularly. Libraries have a long history in dealing with archiving and preservation issues and can say emphatically that a dark archive that links to publishers’ Web sites is an unacceptable alternative, one which the NIH has consistently and wisely rejected.

05/31/2008 at 02:56:21 PM

Luce

Richard

MA

Emory University

Atlanta

GA

USA

Representative NIH Funding Recipient Organization

Question 1: The current embargo period of 12 months is longer than necessary to address the economic concerns of publishers who are interested in protecting their subscription revenue stream and is much too long to effectively promote the advancement of research in the sciences. An embargo period of 6 months would better ensure that the public has access to the published results of NIH funded research. A 6 month embargo would not endanger the revenues of the publishers because libraries will not cancel journal subscriptions because some articles from a journal will appear in PubMed Central after six months.

Question 2: If the NIH manuscript submission process could include a mechanism to notify the institutions of the article’s authors, that information would be very useful to the offices charged with overseeing NIH grant administration. The notification could be at the time of submission or at the time of depositing in PubMed Central. An alternative would be the ability to identify articles deposited in PubMed Central by author’s institution and whether funded by NIH.

Question 3: It would be helpful if the NIH webpage included an RSS feed so notifications of changes could be promptly distributed. An RSS feed would help our institution ensure that the materials we have prepared for our faculty and researchers continues to include the most recent information from NIH. We have found the updated FAQs to be very helpful, but would also appreciate having revisions to the FAQ noted by the date of the revision. We have also shown some slides from the training PowerPoints in our information sessions with faculty and researchers. The list of journals that submit final published articles to PubMed Central is very helpful. A similar list of journals which allow submission to PubMed Central in the language of their publishing agreements would also be helpful to NIH grant-funded authors.

Question 4: Emory University appreciates the opportunity to express its support for the NIH Public Access Policy. The implementation of this policy on our campus has included ensuring faculty and researcher awareness through a broadcast memo, websites, information sessions and newsletters. The Libraries and the Office of Research continue to serve as resources for questions and to collaborate on incorporating compliance with the policy into training programs and information sessions for NIH grant recipients. Implementation of the Public Access Policy has also provided an opportunity for faculty and researchers to more fully understand their rights as copyright owners as well as their obligations under this policy. A greater understanding of copyright as a bundle of rights and the implications of following the traditional model of transferring ALL of their rights under copyright to publishers has provided an opportunity for faculty and researchers to more thoughtfully consider what rights they want and need to retain when publishing. Although authors must take additional steps when publishing their research to ensure compliance with the NIH Public Access Policy, the availability and accessibility of their research in PubMed is appealing to some faculty members since this is their primary search tool (one faculty member asked how he could get all of his previously published articles deposited in PubMed). The accessibility in PubMed of articles by members of the Emory community is congruent with Emory’s vision of working for positive transformation by making discoveries that benefit Emory, Atlanta, and the world. With continued collaboration, the goal of the NIH Public Access Policy to ensure that the public has access to the published results of NIH funded research is both attainable and beneficial to our society.

Question 1: First of all, we would like to thank the NIH for continuing to engage with stakeholders. Universities Allied for Essential Medicines (UAEM), an university student organization with chapters at nearly 40 universities in the United States, Canada and the United Kingdom, believes that the current system established by the NIH represents the best method for ensuring a long-term, stable and effective scientific resource. Scientific innovation is best served when the fewest barriers possible stand in the way of access to knowledge. We applaud the uniform, accessible system that has been adopted by the NIH and would strongly urge that the NIH not consider alternatives that would diminish this simplicity or threaten the long-term viability of the NIH system as a one-stop location for articles resulting from public funding. The current system correctly builds upon the core mission of the university which is to widely disseminate knowledge for the public good.

Question 2: In order for the policy to be effective, enforcement needs to carry a true penalty for failure to comply. For example, in all future NIH grant applications, it should be mandatory that references are included to all previously required PubMed Central deposits. Lack of monitoring and ensuring compliance has led to regular underreporting of university inventions to federal funding agencies under the Bayh-Dole Act.

Question 4: At the most recent World Health Organization meeting of the Intergovernmental Working Group on Public Health, Innovation and Intellectual Property, the policy of promoting access to publicly-funded research through submission of final, peer-reviewed manuscripts to an open access database was adopted. However, the policy recommendation is to strongly encourage and not to make submission mandatory. Given that access to publicly-funded research is becoming the global norm, the NIH has an opportunity to establish the gold standard by maintaining a mandatory and effective system in place.

Question 1: The American Physical Society (APS) is a nonprofit professional organization representing 46,000 scientists in physics and related disciplines. APS publishes approximately 16,000 peer-reviewed papers per year in nine journals. We have long supported the goal of wide access to the scientific literature through mechanisms consistent with the continuing health of peer-reviewed scientific publishing. For example, we have supported arXiv.org since shortly after it was established, we have no embargoes of any sort, and we allow authors to post our final PDF of their articles on their own websites and on their employers’ websites. We also pioneered tiered-pricing models to enhance the accessibility of our journals to smaller educational institutions.

Nevertheless, we have grave reservations about the announced NIH implementation of the Public Access Policy, because we fear that this implementation runs the risk of unnecessarily damaging the economic viability of scientific-society publishers and the integrity of the scientific literature, while at the same time costing the taxpayers significantly more than is needed to achieve the central goals of the congressional public access mandate.

The announced implementation effectively establishes NIH as a duplicate publisher for an unknown fraction of the literature (all papers not directly submitted by publishers) and provides no compensation to publishers for their significant investment in peer-review, scientific editing, composition, copyediting, and electronic hosting and archiving (for example, APS maintains three geographically distributed, continuously updated mirrors of all its content). Furthermore, we are concerned that the final XML files produced by PMC will not be as accurate as those produced by scientific-society publishers, with close scientific oversight (e.g., APS employs approximately 50 full-time Ph.D. editors).

We believe that NIH should immediately begin serious and substantive consultations with publishers to explore a variety of cost-effective alternatives that show more appreciation for the service to the scientific community provided by nonprofit society publishers, and that avoid producing variant archival copies of the same paper. The latter seems a near-certain result of PMC’s plans to perform independent and duplicative composition and copyediting, at taxpayer expense. For example, it would be completely consistent with the public-access legislation for PMC to simply operate a well-indexed repository of publisher-prepared PDFs of all NIH supported articles, including links to publishers’ websites. Nothing in the legislation requires PMC to host full XML files of articles, let alone to spend public funds on the production of its own XML versions.

APS is particularly concerned by the plans of NIH to provide its archive to other entities, including repositories outside of the United States. We see nothing in the legislation that supports the right of NIH to do this, and we believe that it is in clear violation of our copyright agreement and those of other publishers. We urge NIH to abandon these plans voluntarily and immediately.

We are profoundly committed to the dissemination of scientific knowledge. This is central to the APS mission “to advance and diffuse the knowledge of physics.” However, we are equally committed to guaranteeing the accuracy of the public record of the collective scientific literature. We believe that these two objectives are best achieved by nonprofit scientific societies that combine the highest standards of the academy, long-term stability, and the ingenuity and expertise of private enterprise.

Re: Request for Information: NIH Public Access Policy: NOT-OD-08-060 (March 28, 2008) ARVO, the Association for Research in Vision and Ophthalmology, is grateful for the opportunity to respond to the above mentioned NIH Public Access Policy. As stated in previous correspondence, ARVO has over 12,000 members worldwide and publishes two of the top five peer-reviewed journals in ophthalmology, as demonstrated by the Institute of Scientific Information’s Impact and Immediacy Factors. Investigative Ophthalmology & Visual Science (IOVS) receives over 1,600 submissions and publishes over 750 peer-reviewed articles annually; all articles are freely available online to everyone within twelve months after publication. The Journal of Vision includes 300 articles online only, all of which are freely accessible as they are published. Our concerns continue to be as follows.

Intramural Researchers: Policy Interpretation • ARVO recognizes that US-government funded research is in the public domain but does not recognize NIH’s redistribution or claim of ownership of public domain content. • ARVO does not support NIH’s stated practice of depositing US taxpayer-funded articles and/or selected content in non-US sponsored or controlled databases. • ARVO supports the practice of deep archives of scientific articles and is willing to work with NIH to establish a perpetual, deep archive. • The Policy is confusing for authors and PIs; it states that the PI is responsible for submission of accepted articles whether or not they are authors of the articles. In addition, publishers do not have information regarding who is the PI for every grant. • NIH’s unfunded mandate for required deposit of accepted manuscripts policy for intra- and extramural scientists whose research is supported in whole or in part by NIH fails to recognize the value-added features included in the publishing process. ARVO supports and encourages NIH to link to final, published articles and associated supplementary data on trusted publishers’ sites such as HighWire Press. • ARVO explicitly states in its Copyright Form for government employees that NIH-funded authors may submit final, accepted electronic files to PubMed Central. Additional forms are redundant and potentially confusing to authors, institutions, and publishers.

Overall Policy Concerns • NIH’s unfunded mandate for required deposit of accepted manuscripts policy for intra- and extramural scientists whose research is supported in whole or in part by NIH fails to recognize the value-added features included in the publishing process. ARVO supports and encourages NIH to link to final, published articles and associated supplementary data on trusted publishers’ sites such as HighWire Press. • Many associations, including ARVO, have free online access to all back issue content published since the inception of the journal (volume 1, issue 1).

Suite 250 • 12300 Twinbrook Parkway • Rockville, MD 20852–1606 • TEL (240) 221-2900 • FAX (240) 221-0370 • www.arvo.org • This policy severely inhibits publishers’ oversight and control of the use and potential misuse of its intellectual property. • The fundamental financial models of subscriptions and advertising supporting the peer-review process as well as the ongoing educational opportunities and member support provided by Associations’ publications are threatened. The Policy is forcing model changes but does not support publisher charges if an article is accepted and published after the grant has expired, regardless of funding included in the grant. • The Policy and NIH submission process impose the additional burden of proofing and verification activities on Principal Investigators (PIs), affecting research in the short- and long-term. • There are no procedures at the NLM and PubMed Central (PMC) for ensuring that only those articles funded by NIH are made publically available. Currently publishers must monitor PMC and request removal of articles that do not meet NIH’s stated criteria.

ARVO looks forward to working with NIH’s Public Access and NLM staff to resolve these significant issues.

Sincerely yours,

Sally Atherton, PhD Executive Vice President

Nicholas Delamere, PhD Chair, Publications Committee

Joanne Angle Executive Director

05/31/2008 at 12:55:26 PM

Murray-Rust

Peter

D Phil (Oxon)

University of Cambridge

Cambridge

none

UK

Other Member of the Public

Question 1: There is an urgent requirement in bioscience to use machines to extract information from the full-text of papers (”text-mining” mining and “data-mining”). Examples of this use are the machine-assisted annotation of genomes, the extraction of concepts from text and the linking of information from many different disciplines. In my own field of molecular informatics it is possible to scan a million Pubmed abstracts a day and extrcat mention of new chemical compounds of biological interest. It is now well known that abstracts alone do not give sufficient information and that access to the full-text is required.

Many publications are accompanied by data, and indeed for many of these (e.g. about sequences and structures of biomolecules) the data are often more important than the fulltext. Although the STM publishers have urged their members to regard data as facts and therefore free of copyright, several publishers label data as copyright, thus effectively barring the legitimate re-use of data. It is important that the NIH challenges this and forbids it on PMC.

Many data are embedded in the full text and can be extracted by machines (”text-mining”). This process is made more tractable if the text is available in XML form (including XHTML) and I support the use of these formats.

Text-mining” and “data-mining” are hardly mentioned - if at all - in the NIH’s description and requirements. I would therefore wish to see positive indication that the NIH supports the re-use of the material, in high-throughput mode.

Question 3: The information provided gives users very little positive indication that the can legitimately re-use the material published on PMC. I write a blog on Open Access and Open Data (http://wwmm.ch.cam.ac.uk/blogs/murrayrust) and the informed opinion was that PMC does not allow data- or text-mining and that attempts to do this will result in the NIH server cutting off access to the given IP. The words “fair use” are useless. In practice no scientist has enough knowledge of case law to know what is and is not fair use and the term effectively frightens many into “no use”.

I would urge that the NIH make clear what their policy on data- and text-mining is, using those terms. I would also suggest that the NIH add machine-readable versions of licences or similar documents so that robots are aware of what they may and not do.

Question 4: I am a user of the material available on the NIH sites, including PubChem, and PubMed. The volume of information is now so great that machines are essential to use it properly. I believe it is essential for the NIH to enable text/data-mining of its information if it is to recoup the maximum value of its research investment.

05/31/2008 at 11:49:24 AM

Ruben

George

PH.D.

Dartmouth College & Editor-chief-Microscopy Research & Technique

Lebanon

NH

USA

Representative NIH Funding Recipient Organization

Question 1: Whatever version of the article PubMed Central lands up with the publisher is responsible for producing and maintaining the final published version which authors, for example, will need to cite. ?? Why is PubMed Central using its own article numbering system (PMCIDs) and not the internationally accepted DOI (Digital Object Identifier) system on which the CrossRef linking is based? ?? Why is PubMed Central not giving clear acknowledgement to the original publication and a link to this on the publisher’s site? The statutory language of the mandatory Public Access Policy applies to “all investigators funded by the NIH,” yet does not specify whether the NIH funding is in whole or in part. NIH takes the view that the policy applies to investigators with any NIH intramural research funds or any amount of direct costs funded by NIH, even if the funding is insignificant and supplemented by other public or private sources. ?? What if these other sources oppose the posting of their funded work on PubMed Central? The policy also holds that “Principal investigators and their institutions are responsible for ensuring all terms and conditions of awards are met.” Yet, this includes the submission of articles that arise directly from the investigators’ NIH-funded research even if they did not author or co-author the publication. In fact, NIH-funded investigators and institutions are being held responsible for making sure that these other authors are “aware of and comply with” the NIH policy. How could they possibly be able to comply with this provision? What will the repercussions be for investigators and journals who do not follow the process? Will NIH stipulate that its requirement for the deposit of peer-reviewed manuscripts in PubMed Central only applies when NIH funding represents the sole funding for the scholarly work? Will NIH also modify its guidelines to state that its deposit requirement only applies to peer-reviewed manuscripts that report findings of empirical research and does NOT apply to literature reviews?

Question 2: Since journals are responsible for maintaining proof edited & corrected published paper on line, doesn't it make sense to ask the journals to deposit a web site link with pubMed on the date that an article is published in the paper journal version. The acknowledgements will have to state clearly that the work was funded by NIH for this to occur. This could eliminate a huge expense of independently putting papers onto a Pubmed website and maintaining that website into the future and the final version of the paper will be the same at the journal publisher and at Pubmed. This will also maintain the watermark of the original copyrighted paper.

Question 3: The new policy will affect all stakeholders in the scientific research community and may have a particularly severe impact on small society publishers as subscription revenue will decline with increased free access on Pub Med Central. Will NIH provide publishers with detailed and robust PMC usage statistics that will enable them to assess the impact of PMC usage of their subscriptions? What oversight or governance will monitor whether NIH’s performance in pursuit of its intended purpose is a) met; b) not costly for the taxpayer; c) not burdensome on research investigators; or d) does not have a demonstrably negative impact on the integrity of the scientific and medical literature (e.g. errors and versioning problems introduced, economic harm to journals and publishers)? What limitations, if any, would be imposed on PubMed Central as an “aggregator” of content from sources such as HHMI, Wellcome Trust, other U.S. government agencies, etc? What steps will NIH take if it is found that its Public Access Policy is hurting rather than advancing scientific research?

Question 4: The cutting-edge research that the many societies publish is rarely obsolete within a year, and may have a shelf life of five to ten years. It is imperative that adequate financial compensation be offered by NIH to offset the loss of income that publishers will experience resulting from all accepted, peer-reviewed manuscripts funded by NIH being made publicly available within such a short period of time. What latitude will NIH have in negotiating terms and conditions directly with publishers and other rightsholders who might wish to undertake direct licensing arrangements with NIH that would enable the deposit of copyrighted works on behalf of authors? Specifically, will NIH be empowered to negotiate such licensing terms, including payment, on a publisher-by-publisher basis, as certain non-government funding agencies have done? The policy provides for publisher deposit of final published articles on behalf of authors, and includes allowance for the use of grant funds in the payment of publication fees levied on NIH-funded authors. How will such funds be identified in the grant and what has NIH budgeted per year for such costs over the next five years?

05/31/2008 at 11:37:44 AM

English

Ray

Ph.D.

Director of Libraries, Oberlin College

Oberlin

OH

USA

Representative NIH Funding Recipient Organization

Question 1: I support the NIH policy in its current form. It is a major step forward that will produce significant new benefits for researchers and the general public. It will greatly increase the effectiveness of our government's investment in scientific research. While I favor the policy wholeheartedly, I do encourage NIH to develop a strategy to reduce the embargo period from the current twelve months. Given the time-sensitive nature of biomedical research, a six-month embargo, for example, would substantially increase the benefits realized from the policy. It would also make NIH's policy consistent with public access policies in other countries. Suggestions have been made by some publishers that NIH should implement a policy that involves linking to publishers' websites. NIH should reject this idea, not only because it would be a poor substitute for the current policy, but also because it would be contrary to the legal obligations of the agency. The language of the law is clear: electronic versions of final peer-reviewed manuscripts must be submitted to PubMedCentral and those manuscripts must be made publicly available in PubMedCentral.

Question 2: 1. NIH should track and provide regular and frequent public updates on the percentage of eligible articles that are deposited and made public. 2. NIH should commission a study, or collect data, on any impact that the policy may have on journal subscriptions. Such a study could help resolve the issue of the policy's potential impact on journal cancellations and resultant threats to peer review. As a librarian, I am confident that libraries will not cancel journal subscriptions as a result of the policy. Final peer-reviewed manuscripts in scientific fields (biomedicine in particular) that become available well after publication are not an adequate substitute for current journals. A carefully crafted empirical study could document whether or not my view is valid. It could also document any potential effects from policies that incorporate shorter embargo periods. 3. NIH should maintain a list of publishers that have publishing agreements that are consistent with the policy.

Question 3: NIH should increase its efforts to make clear that investigators are required to submit their manuscripts upon acceptance for publication, and not upon publication itself or at a later date. While the language of the law is very specific in that regard, there is significant misunderstanding about the required time of deposit.

Question 4: I greatly appreciate NIH's willingness, which now extends over several years, to consider comments from all parties concerned about the public access policy. The policy has now been vetted in numerous ways in numerous venues; everyone has had ample opportunity to comment. NIH's implementation plan follows the language of the statute carefully and it is fully in compliance with copyright law. The law is a well-thought out compromise that is appropriate at this juncture. The twelve-month embargo clearly protects publishers interests while ensuring eventual access to the results of all NIH-funded research. I congratulate NIH on the implementation of the policy and look forward to seeing data that will document its success.

05/31/2008 at 07:15:53 AM

Arunachalam

Subbiah

M Sc

Independent Researcher / Writer

Chennai

Tamil Nadu

India

Other Member of the Public

Question 1: You might wish to hold both the institution and the individual receiving NIH funds responsible for depositing the full text of the papers resulting from NIH funding immediately on acceptance.

Question 2: It is OK to have a law in place, but it ill not be of much use if it is not implemented well. It is absolutely necessary to have a mechanim of monitoring compliance of the law and make sure that every author who receives NIH funding deposits the full text of all papers resulting from the NIH funds. There should be a penalty clause for those who fail to comply.

Question 3: Ther should be continuing advocacy campaign. One of the problems today is that not many publishing researchers are fully aware of OA and its advantages.

Question 4: The embargo (of up to one year) should be abolihed and you should insist on immediate open access. Also, the US Government should pass a legislation to the effect that would make it illegal for journal publishers to forbid authors from placing the full text of their papers in an open access repository such as PubMed central or institutional repositories.

05/30/2008 at 11:55:38 PM

Bitkower

Jay

MS

Actoin to Cure Kidney Cancer

New York

NY

USA

Patient or Representative of a Public Health Advocacy Organization

Question 4: I recommend that researchers deposit their articles to the NIH within 6 months of publication. As a cancer advocacy organization, we advise cancer survivors as to the trial results of latest therapies and other information relevant to the survival issues of cancer patients and caregivers. Currency of the information can be crucial to one making critical helath care decisions. For us to subscribe to several journals or evenhave to pay $30-80 for each individual article would be prohibitive. The 6-month timeframe is fair to the journals because the vast amount of their subscriptions comes from libraries, which would retain their subscriptions in any case. Therefore, the journals would lose little revenue, but the cancer community would greatly benefit fromthis change of policy.

05/30/2008 at 09:57:40 PM

Douglas

Kimberly

M.A., MSLS

California Institute of Technology (Caltech)

Pasadena

CA

USA

Representative NIH Funding Recipient Organization

Question 1: Caltech appreciates the opportunity to comment and to also register its support for NIH's policy to ensure broad-based public benefit from research for discovery innovations, learning enrichment, and clinical care.

The Offices of the Vice Provost for Research, Sponsored Research, Library, and General Counsel at Caltech undertook the following for successful implementation of the NIH Public Access Policy: 1) Crafted text for authors to include in their manuscript submission letters to address copyright in a manner consistent with the law. 2) Individually notified every NIH grantee of the steps to undertake. 3) Met with research groups to address compliance needs. 4) Created and added a number of web pages announcing, explaining, and providing compliance steps to the Caltech community. 5) Consulted and advised one-on-one in labs and offices, as well as electronically, regarding the policy and related PubMed Central manuscript submission process

The NIH should continue to urge publishers to automatically deposit papers in the PMC and find appropriate ways to recognize those who do. In addition, with incentives from funding agencies such as the NIH and given today's available technologies, universities and publishers need to establish effective new mechanisms for handling peer-review certification and optimizing world-wide research paper distribution. New more collaborative approaches borne of the network are needed.

Question 2: It will be helpful for the NIH to consider the following: 1) Automatic notifications of author institutions when papers are submitted to the PMC, 2)Straightforward search or link in PubMed to identify institution NIH funded papers, 3) Collaboration with institutional repositories to achieve the stated goal of public access in the most cost effective and persistent manner for all.

Question 4: We observe that the NIH Public Access Policy is consistent with the Copyright Law Title 17 U.S. Code in which the authors who originate the work in tangible fixed medium claim the copyright and can license the work's use or transfer the copyright as suits their purpose. The Copyright Law does not support one business model over another.

Also, Caltech has no intention of canceling journal subscriptions due to the NIH policy. However, like all organizations, it must operate within a budget. Regrettably, it does occur that some publisher prices exceed our ability to pay. Therein rests the source of any journal cancellations, not public access mandates. Therefore the limits on an embargo could easily be shortened to 6 months without changing the decision-making process we undertake.

University based research is fundamentally driven by the desire for public benefit. Caltech welcomes the leadership of the NIH in creating change and dialog so that publicly funded research can realize the full potential made possible by the global network.

05/30/2008 at 07:54:30 PM

Boney

Evans

Ph. D. Candidate

Caltech Graduate Student Council

Pasadena

CA

USA

Representative NIH Funding Recipient Organization

Question 4: The Caltech Graduate Student Council (with myself as chair) is a strong advocate of this policy, views the NIH as particularly progressive in this respect, and would go so far as to recommend a similar system to the NSF and other government funding agencies. At our meeting on June 5 we will be considering a resolution urging Caltech to take action along these lines, and are actively seeking alliances with other graduate student councils to encourage similar measures at universities nation-wide.

We think that journals should not have the sole right to reproduction of our work, and that maintenance of this copyright is fundamental to our careers in science. From a political standpoint, we think that no government organization should provide support for research that is not accessible to the public for free through a service like this.

As future researchers having spent the majority of our academic lives with the aid of the internet, we recognize that a change to open-access is coming. In previous generations, part of the service provided by journals was dissemination of knowledge, and maintenance of copyright was necessary to this service. In the age of the internet, this is an already obsoleted role, as a simple pub-med search will show. We are routinely surprised that publishing involves a transfer of copyright, and we no longer accept this as a necessity of the dissemination of information.

To the creators of the NIH Public Access Policy: Please stand by your change. Complaints about being unable to cope with the "huge inconveniences" imposed by the plan are overstated, and complying with additional requirements by funding agencies is part of the job as far as we are concerned. We look forward to putting our papers in a Caltech repository in the not-too-distant future, and, those of us supported by NIH grants jump at the chance to put them here.

05/30/2008 at 06:39:32 PM

Hume

Wyatt R.

Ph.D.

University of California

Oakland

CA

USA

Representative NIH Funding Recipient Organization

Question 1: As discussed in the response to Question 4 below and in the attachment, to reduce the administrative burden and confusion resulting from the varied and uncoordinated roles of authors, PIs, institutions and publishers in ensuring compliance with the NIH public access policy, UC strongly recommends that NIH undertake a systematic program, working with publishers and institutions, to develop a consistent and streamlined procedure for deposit that addresses rights questions and other implementation issues and can be used by all NIH-funded PIs without reference to the specific policies and practices of individual journals and publishers. UC would be glad to work with NIH and interested peer institutions to develop and implement this.

Question 2: The development of the simplified procedures described Question 4 below and in the attachment would represent a great stride in reducing barriers to compliance for PIs and institutions and consequently would significantly diminish the need for case-by-case monitoring. In addition, in view of the complexities discussed above, we believe it important for NIH to acknowledge that full implementation of the policy and associate compliance measures will require an extended period of transition from current practices. It will be important not only to provide clarifications that will be helpful to investigators and their institutions, as suggested in the response to item 3 below, but to provide assurances that any penalties for non- compliance will not be unreasonably applied as long as significant uncertainties remain.

Question 3: Simplification would greatly reduce operational complexity and therefore the burden that must now be borne by NIH and institutional information, training and communication activities. In addition, as noted above, we recommend that NIH develop tools and informational resources addressing:

o How to deposit, including how to use the deposit tools provided by NIH, and clarification of the respective responsibilities of the author(s) and the Principal Investigators.

o What to deposit, including more expansive information about which version of the work to deposit, and clarification of the applicability of the policy with respect to the funding year for the supporting grant. In this regard, we note that NIH's own documents conflict with one another: the Policy says that it applies to all articles arising from NIH funding that are accepted for publication on or after 4/7/08, but the FAQ has a further limitation to articles that arise from FY08 funding.

o How to identify, control and manage the multiple versions of works; we continue to hear continued expressions of concern and uncertainty about the existence of multiple versions

Question 4: UC continues to be deeply concerned about a significant and fundamental structural issue: the current policy does little to address underlying complexities associated with the loosely-coupled roles of authors, Principal Investigators, institutions, and publishers. This situation gives rise to several problems that the University has experienced in the early days of implementation of the policy. For example, publishers are under no obligation to assist, or even permit, authors to retain the rights needed to deposit their manuscripts in PMC in compliance with the policy, and the authors' institutions generally have neither the legal standing nor the means to intervene. The ambiguity about rights is amplified by the fact that publishers have a variety of practices that relate to NIH compliance: some automatically deposit either the final published article or the author's final peer-reviewed manuscript in PMC, others have publication agreements that permit the authors to deposit, others authorize compliance only through the mechanism of an optional "author pays" publication agreement, yet others provide unrestricted open access to all their publications, and so on. The requirement to track the details of this complex environment, to respond correctly for each NIH-sponsored publication, and to deal with the situations where the necessary rights are unavailable, or only available for a fee, gives rise to most of the implementation problems UC has experienced to date and imposes a substantial administrative burden on the NIH, on grantee institutions, and on NIH-supported researchers. We note further that confusion on this point is likely to have its greatest effect on younger researchers who may be disproportionately disadvantaged when the most prestigious publisher in their field does not comply with the Policy, and that the unresolved ambiguities may lead more publishers to offer "author pays" models as a means to comply with the policy, unnecessarily diluting the funding available to directly support research and forcing authors to confront yet another difficulty when publication occurs after the award period.

UC therefore strongly recommends that NIH address this problem by establishing a systematic program, working with publishers and institutions, to define a single, simple model that facilitates and supports deposit of NIH-sponsored works in PMC. The submission of Anthony De Crappeo, on behalf of the Council on Governmental Relations, on May 28, 2008, expresses concerns similar to those of UC and reaches a similar conclusion. The University of California has extensive relationships with most major biomedical publishers, both as a purchaser of journal publications, and, through its faculty, as a supplier of the work that they publish. UC is willing to work with NIH and like-minded peer institutions to plan and implement such a program.

Question 4: Based on a recent experience working with a student, I am concerned about the difficulty students (and perhaps some more advanced authors) will have in distinguishing the different kinds of articles available in PubMed Central. Link icons in PubMed send users to “Free Author Manuscript in PubMed Central” and “Free Full Text Article in PubMed Central”. The link icons for both of these options look very similar. In addition, the user following these link icons goes to articles with very similar formatting and coloring.

A student preparing a published work such as a masters’ paper, a doctoral thesis or a journal article should read and cite the final edited paper whenever possible. In order for students (and other researchers) to distinguish the author manuscripts from the final articles in PubMed Central, they need to look very different. The information on the author manuscript that a final edited version is available elsewhere needs to be made much more prominent (perhaps enclosed in a box.) The appearance of the author manuscripts should be quite distinctive from the final articles in PubMed Central (perhaps with a different color header.) It would also be helpful to add information about how to cite an author manuscript as an author manuscript on both the web version and the PDF version of the author manuscript.

Look at the following two citations in PubMed, and the two articles in PubMed Central to see how difficult it is to distinguish between final articles and author manuscripts:

Question 1: The Association of American Universities (AAU) is an association that includes 60 leading public and private U.S. research institutions. AAU focuses on issues important to research intensive universities, such as funding for research and scholarship, science policy issues, and graduate education. The goals of university research are the discovery, creation and dissemination of new knowledge for the benefit of society. Scholarly publishing is one of the major means of dissemination of new knowledge, and, accordingly, AAU also focuses on scholarly communication and related intellectual property issues.

AAU, on behalf of its member university presidents and chancellors, has repeatedly endorsed NIH’s efforts to increase public access to the results of NIH-funded research through the implementation of its Public Access Policy. Most recently, as the FY08 House Labor/HHS Appropriations Act was about to be debated on the House floor last summer, AAU President Robert M. Berdahl wrote to Subcommittee Chairman David Obey endorsing the Section 217 language that prompted NIH’s new guidelines. We welcome this additional opportunity to offer our support for the appropriations language and NIH’s progress in implementing it. Indeed, NIH’s effort to assure that everyone who has a view is heard has been much appreciated in the research university community.

Our member institutions have responded to NIH by developing policies and procedures to alert, educate and assist faculty in complying with the new requirements. Generally speaking, our administrators appreciate the effort that NIH has put into the complex exercise of developing and communicating the new requirements.

Question 2: We offer the following suggestions about how to improve NIH’s implementation of the Public Access Policy’s mandatory submissions requirement.

• We seek NIH’s help in negotiating a blanket permissions agreement with the publishers that will greatly ease the transaction costs that are currently borne not only by individual authors and, by extension their institutions, but also by publishers. What is needed is a modified standard copyright agreement acknowledging that the author retains the right to provide a copy of the final manuscript to NIH for posting by NIH on PubMed Central within 12 months of publication by a given journal. We request that NIH work to encourage publishers to adopt such agreements.

• If, as we hope, more publishers adopt such agreements over time, it would be helpful if NIH maintained and posted an easily accessible and authoritative list of publishers whose author agreements provide blanket permissions for authors to comply with the NIH Public Access Policy.

• NIH might also consider an automatic notification system for designated campus entities (an institution’s Office of Sponsored Research, for example) when a faculty member from that institution has deposited an article in PubMed Central. If the relevant institutional office is also notified when a faculty member receives electronic confirmation that his or her paper has been deposited, institutions would not have to go to additional and unnecessary effort to confirm the transaction.

• As institutions have put significant effort into establishing policies for the submission of articles to PubMed Central, educating and providing technical assistance to faculty, and requiring faculty to certify that they have complied, we would request that NIH develop a “safe harbor” for institutions that have met their responsibilities. If grantee institutions which have made good faith efforts to assure compliance of faculty, we believe such institutions should be shielded from the consequences of non-compliance, especially when that non-compliance arises from circumstances beyond the institution’s control.

• NIH should monitor (or perhaps have a third party such as the National Academies of Science analyze) the impact of the implementation of its Public Access Policy on scholarly publishing and trends in faculty publishing decisions as well as the costs associated with compliance under the new policy.

Question 4: Thank you for the additional opportunity to comment on implementation of NIH’s Public Access Policy.

05/30/2008 at 05:46:18 PM

Duranceau

Ellen

MLS

Massachusetts Institute of Technology (MIT)

Cambridge

MA

USA

Representative NIH Funding Recipient Organization

Question 4: Some have called for NIH to offer links to journal articles at publishers’ websites, supporting only a dark archive. At MIT, we believe this method would not result in a reliable, permanent archive or in stable open access to NIH’s publicly funded research. Frequent shifts that occur among publishers, journal titles, and interfaces would make it extremely labor-intensive to offer consistent access through a list of links. The result is likely to be many broken links, with attendant barriers to access. In addition, preservation is more difficult to manage well when an archive is not actively used. These problems, along with the loss of a simple, direct access model, would undermine the concept of the archive.

05/30/2008 at 05:26:26 PM

Adler

Allan

Association of American Publishers

Washington

DC

USA

Other

Question 1: Introduction

The members of the Professional & Scholarly Publishing Division of the Association of American Publishers appreciate NIH’s vision for “an interconnected world of science” and continue to support efforts to enhance public access to scientific research with many of our own innovative online tools. However, we are troubled both by NIH’s unwillingness to acknowledge the Public Access Policy’s flawed legislative process to date and by the lack of concern for any dislocation that will result from adhering to NIH’s “implement and steer” approach for this major shift in policy. Improper implementation of this sweeping mandate has serious implications for all stakeholders in the research community (publishers, authors, the public) and for science itself, and these implications should be fully considered and addressed as soon as possible. Our key policy and implementation concerns include: Copyright. Blanket requirements in grant contracts would effectively deny authors and publishers the benefits of their copyrights—the most fundamental of which is the ability to decide how and in what form their works may be distributed—in conflict with fundamental copyright principles and without compensation for the value added by publishers and editors. In effect, the application of the NIH policy is an imposition of an extraordinary and unprecedented exception or burden to the copyright works—and thus diminishes their value for any journal business model that relies on exclusivity to drive traffic, advertising and subscriptions. The NIH policy essentially mandates a business model that can accommodate this “burdened” copyright, a model that must be based on up-front submission or publication charges, rather than the current models of the vast majority of journal publishers. This does not seem to us to be consistent with the legislative mandate to implement the NIH policy consistent with copyright. Other alternatives to the NIH policy of mandated centralized posting on PMC can and should be considered, alternatives that would still be consistent with the legislative mandate of public access within 12 months of publication. Quality Control and Compliance with Publisher Policies. Many manuscripts currently appear on PubMed Central (PMC) in violation of publisher policies. How will NIH ensure under the new public access policy that individuals post the correct manuscript version to PMC to be publicly available at the correct time, consistent with publisher agreements? For publishers submitting directly, how will NIH ensure that articles will not be accepted from individuals or entities other than the publisher? Scope. The revised mandatory public access policy now calls for submission of review articles. This is of concern to publishers especially since NIH previously encouraged us to add review articles to our journals as a way to protect our subscription base under the voluntary policy. Editors commission the review articles based on the scientific expertise of scientists; they are not based on specific research projects supported by NIH research grants. Furthermore, requiring that review articles be included will seriously undermine the many journals that publish review articles only. Repurposing. Changes made by NIH or authors that will result in variations from the original manuscript are of considerable concern for a number of reasons, not least of which is the potential introduction of errors. NIH needs to ensure that no changes, such as substantive editorial changes, are made to the manuscripts other than obvious errors in NIH production process or perhaps improved graphics for related illustrations. Links to other databases also raise concerns about changing an article’s principal context and focus. NIH needs to identify precisely how manuscripts will be linked to databases and other resources to ensure the editorial integrity of the underlying work.

Patient education. Although we understand that the principal motivation of the legislative mandate to be patient information and education, the NIH policy implementation does not address this need directly (focusing instead on building researcher infrastructure). Publishers have been working actively with voluntary health organizations (VHOs), and we believe that more should be done in this area by NIH – hopefully, working with publishers and VHOs. Piracy. Third parties could commercially exploit content that appears on PMC without the consent of the publisher. What safeguards will NIH put in place to prevent copyrighted material available on PMC from being altered, pirated, made into derivative works, redisplayed, republished, resold or used for any other commercial purpose?

These represent only a few of our many practical concerns related to implementation of the mandatory policy. Below is a more expansive “checklist” of publisher questions.

We hope it is clear that publisher concerns reflect not only critical issues related to the spirit and protection of copyright but those aspects affecting day-to-day management of the policy and how effectively it achieves its stated objectives. We believe that we can work with NIH to arrive at practical solutions to these concerns, but that will require regular, ongoing consultation and discussion. In light of the substantial nature of these questions and NIH’s commitment to the advancement of science, we believe it is important that NIH fully address these questions. We look forward to a positive and constructive interaction with NIH that will result in balanced implementation of the new public access mandate in a way that addresses our concerns, advances science and benefits the public.

Question 3: Implementation of the NIH Mandatory Public Access Policy Additional Publisher Concerns Raises Many Questions: NIH needs to ensure that the implementation of the policy will respect the basic principles embodied in copyright and not undermine those rights that provide incentives for publishers to invest in peer-review, publishing and the communication of scientific and medical research. Without review and significant changes, the mandatory Public Access Policy could have unintended and undesirable consequences. The issues that must be addressed include: Consultation: NIH Dialogue with Publishers, Societies and Authors Non-profit and commercial publishers, societies and researchers are not only seriously affected, but also critical to the proper implementation of the policy. A formal and ongoing consultative body that includes stakeholders, and with Administration and Congressional oversight, will help ensure that a successful public access model is developed. We urge NIH to conduct regular meetings with publishers and provide regular progress reports on the matters raised by publishers.

· Many investigators are not aware of the new policy. Does NIH have a formal mechanism and the necessary resources to handle the questions that will arise from authors and journals?

· What is NIH’s timeline for amending this policy moving forward?

· What mechanism will NIH put in place to continue the dialogue with publishers that will help ensure this policy is “implemented and steered” effectively and that publisher concerns are addressed? Overview: Copyright Concerns Journals add considerable value to published papers by managing peer review and providing copyediting and design revisions to improve the validity of the published product, benefiting researchers, the public, and the scientific community. The expense and effort of this process is supported entirely by the journals, not by NIH. Under the mandatory policy, significant copyright interests are being taken from publishers, without compensation for their investments. Other related responsibilities undertaken by publishers that bolster the scientific enterprise and thereby add value to individual scholarly works include: editorial selection of manuscripts to be published, marketing, distribution, and preservation. Publisher business models involving subscriptions, transactional paid access to individual articles, and advertising support within traditional publishing and on publisher web sites driven by the distribution of “new” articles, all of which depend on traditional copyright protection, will be impacted by the policy as announced. · Shouldn’t NIH support the full value of copyright and their use in business models including those which involve driving traffic to a publisher site, and permit linking to publishers’ web sites, rather than requiring deposit at PubMed Central? Brand Protection, Repurposing and Piracy It is critical that NIH implement the Public Access Policy in a manner consistent with intellectual property protection and the intent of the related Congressional mandate, and work with publishers in ensuring such implementation. · What mechanisms will NIH put in place to ensure that any revisions to copyrighted materials such as reformatting, enhancing, linking or otherwise changing the articles respect the integrity of the copyrighted content it receives? What assurance will NIH give that this will be done in accordance with guidelines agreed to with publishers?

· Will NIH identify precisely how manuscripts will be linked to databases and other resources, and which databases? Publisher concerns about links include: a) Would links within the article obscure the information in the text? b) Would it change the editorial emphasis by seeming to suggest that certain information within the article is more important than other information, simply because there is a link? c) Would it be appropriate to change that emphasis in the context of the research and the article’s focus?

· How will NIH ensure proper protection of publisher or society trademarks and branding? Not only has there been no affirmation of these markers of quality, but all too often branding information is missing, potentially misleading users to the erroneous conclusion that the NIH is claiming copyright, or that the content is in the public domain.

· It is critical that NIH respect the rights of copyright holders to stipulate what NIH will or will not allow related to third-party use of its works. Will NIH ensure that manuscripts are not distributed to other sites around the world besides PubMed Central? Will NIH implement guidelines that explicitly prohibit third parties from exploiting content that appears on PMC without the consent of the publisher?

· How will NIH prevent piracy of the articles from PubMed Central? Third parties could commercially exploit content that appears on PMC without the consent of the publisher. Will NIH prevent copyrighted material available on PMC from being altered, pirated, made into derivative works, redisplayed, republished, resold or used for any other commercial purpose? What will happen if piracy is discovered as a result of downloading of content from PubMed Central and will NIH notify publishers?

· If deposited content will be “mirrored” to other sites outside the U.S., after publisher approval, how will the sites be established, and how would national and international copyright considerations protect rights holders? What guidelines will NIH agree to with publishers before any distribution of copyrighted content occurs on PMC international mirror sites? Compensation While taxpayers pay for the scientific research on which journal articles are based, non-profit and commercial publishers expend hundreds of millions of dollars a year in the peer-review of manuscripts and in preparing journal articles for publication and timely dissemination in print and online. The cutting-edge research that the many societies publish is rarely obsolete within a year, and may have a shelf life of five to ten years. It is imperative that NIH provide reasonable compensation to publishers for their investments and the well-recognized value that they provide to peer-reviewed manuscripts based on NIH-funded research.

· What latitude will NIH have in negotiating terms and conditions directly with publishers and other rightsholders who might wish to undertake direct licensing arrangements with NIH that would enable the deposit of copyrighted works on behalf of authors? Given that NIH’s policy would amend many journal copyright policies and effectively reduce the value of those rights, will NIH be empowered to negotiate such licensing terms, including publication charges/payment, as certain non-government funding agencies have done?

· The policy provides for publisher deposit of final peer-reviewed manuscripts on behalf of authors, and includes allowance for grantees to use grant funds in the payment of publication fees. How will such funds be identified in the grant and what has NIH budgeted per year for such costs over the next five years? Scope The statutory language of the mandatory Public Access Policy applies to “all investigators funded by the NIH,” yet does not specify whether the NIH funding is in whole or in part. NIH takes the view that the policy applies to investigators with any NIH intramural research funds or any amount of direct costs funded by NIH, even if the funding is insignificant and supplemented by other public or private sources. · If there are other funders, what will researchers be expected to do if these other sources oppose the posting of their funded work on PubMed Central?

· Will NIH agree to stipulate that its requirement for the deposit of peer-reviewed manuscripts in PubMed Central only applies when NIH funding represents substantial funding for the research on which the scholarly work is based?

· The policy also holds that “Principal investigators and their institutions are responsible for ensuring all terms and conditions of awards are met.” Yet, this includes the submission of articles that arise directly from the investigators’ NIH-funded research even if they did not author or co-author the publication. In fact, NIH-funded investigators and institutions are being held responsible for making sure these other authors are “aware of and comply with” the NIH policy. How could they comply with this provision?

· What will the repercussions be for investigators and journals that do not follow the process?

· Will NIH modify its guidelines to state that its deposit requirement only applies to peer-reviewed manuscripts that report findings of empirical research and does NOT apply to literature reviews?

Integrity of Research, Quality Control and Meaningful Public Access The NIH posting of peer-reviewed manuscripts accepted for publication compromises the quality of scientific publishing by ultimately making available two different versions of scientific papers. The first is the inferior, peer-reviewed manuscript that has not yet benefited from the final copyediting, fact-checking, and proofreading required for formal publication, and the second is the definitive, publisher-authenticated version. Given the new policy requiring deposit of NIH-funded manuscripts in PubMed Central upon acceptance, there are some procedural issues that are unclear. In addition, the benefit of access to manuscripts by patients and the general public has never been fully assessed and alternatives such as lay summaries may be far more useful. NIH should ensure that the implementation of the policy is truly beneficial to the public and does not displace other useful models. · How will the NIH know the final month of publication when the month is not always established upon acceptance to a journal?

· Many manuscripts currently appear on PMC in violation of publisher policies. How will NIH ensure under the new public access policy that individuals post the correct manuscript version to PMC to be publicly available at the correct time, consistent with publisher agreements? Will NIH ensure that embargo and posting policies are implemented on a journal-by-journal level or at least publisher-level? Will NIH provide a detailed description of the process at NIH to monitor and ensure prompt take-down of manuscripts improperly submitted?

· For publishers submitting directly, how will NIH ensure that manuscripts will not be accepted from individuals or entities other than the publisher?

· How will NIH ensure that researchers are not misled as to the accuracy and validity of manuscripts on PMC? Will there be pointers to final published versions on publisher sites? One possibility is for NIH to develop a special section within PMC for members of general public/patients to “land” on suitable information for patients and “disclaimers” that the PMC author manuscript represents only a small part of the literature, with references and links to VHOs, Patient Inform, publisher sites.

· How will NIH deal with plagiarism and ethics issues? Will NIH establish guidelines in consultation with publishers on how to deal with corrective notices, corrigendum, and retractions?

Cost The mandatory public access policy will not change the cost of scientific publishing, but will shift the burden of that cost away from scientific publishers and onto authors and the government, in other words, onto taxpayers. · NIH faces funding shortages from the federal government. How much will it cost to effectively implement this policy?

· Does this cost detract from funds to grantees actually conducting the innovative research that advances science? Measuring Impact and Effectiveness The policy will affect all stakeholders in the scientific research community and may have a particularly severe impact on small society publishers as subscription revenue will likely decline with increased free access on PubMed Central. It is important for NIH to ensure that content on PMC will not displace the definitive published version and that publishers brands are not diminished. NIH needs to ensure that PMC does not undermine the viability of journals whose economic stability varies widely. · Will NIH provide publishers with detailed and robust PMC bibliographic usage statistics that will enable them to assess the impact of PMC usage on their subscriptions?

· What oversight or governance will monitor whether NIH’s performance in pursuit of its intended purpose a) is met; b) is not costly for the taxpayer; c) is not burdensome on research investigators; or d) does not have a negative impact on the integrity of the scientific and medical literature (e.g. errors and versioning problems introduced, economic harm to journals and publishers)?

· What steps will NIH take if it is found that its Public Access Policy is hurting rather than advancing scientific research?

Question 4: Yes, we are submitting two documents for the RFI record in a timely manner via email to PublicAccessComments@NIH.gov, as directed by Neil M. Thakur, Special Assistant to the NIH Deputy Director for Extramural Research, in a May 29-30 email exchange with James F. Segroves of the law firm of Proskauer Rose LLP, based on Mr. Thakur’s confirmation that the PDF format used for those documents is not suitable for posting to NIH through this submission template. Unfortunately, the transformation of these documents to a "txt" format could not be achieved in a practical manner.

The two documents submitted for the RFI record are, respectively:

A letter addressed to me by Jon A. Baumgarten of Proskauer Rose LLP, dated May 30, 2008, in response to my request for an analysis of the relationship between the NIH Final Policy on Public Access and certain aspects of U.S. and international copyright law; and,

A letter addressed to Dr. Elias Zerhouni by the Chair and Vice Chair of the Executive Council of the Professional & Scholarly Publishing Division of the Association of American Publishers, dated March 17, 2008, which originally was timely submitted to NIH in response to its request for comments on the implementation of the NIH Public Access Policy pursuant to NOT-OD-08-057 (March 7, 2008).

Both of these documents raise important issues regarding compliance with the statutory proviso that Congress included in Division G, Title II, Section 218 of the Consolidated Appropriations Act, 2008 (Public Law 110-161) to make sure that “the NIH shall implement the public access policy in a manner consistent with copyright law.”

We appreciate the opportunity to provide these additional materials to NIH and thank you for ensuring that they will also become part of the record in response to the RFI.

Question 4: We are writing in response to the request for information about the NIH Public Access Policy (NOT-OD-05-022). As one of the nation's leading public research universities, UCLA takes very seriously its responsibility to serve the people of Southern California, the U.S., and the world through its mission of education, research, and service. An integral part of that mission is the dissemination of scholarly information as broadly and freely as possible, which is essential to furthering scientific discoveries, creating innovative solutions to pressing problems, and improving the lives and well-being of individuals and of society.

To ensure NIH-funded researchers' awareness of and compliance with the public access policy, staff from the Office of Intellectual Property – Industry Sponsored Research, the Office of the Vice Chancellor for Research, and the UCLA Library have collaborated on designing a multi-pronged approach involving both education and assistance. This coordinated effort targeted at faculty, librarians, and staff aims to inform, educate, and assist researchers and to support the broadest possible dissemination of their work. Staff from all three of these organizations participated in a webinar organized by the University of California Office of the President. At UCLA, the Library has taken the lead in providing individual assistance to authors who have questions about the submission process.

We support the NIH Public Access Policy as a very strong step taken toward ensuring that the results of publicly funded research are widely disseminated and available in a permanent, stable archive, though we are aware that some problems must still be overcome. The submission process must be simplified, by persuading all publishers either to join those who submit papers to PubMed on behalf of their authors or to permit authors to deposit papers without additional charges or difficult contract negotiations. In addition, a clearer explanation is needed to clarify the difference between the PubMed Central identification number and the PubMed identification number and about whether either can be used in submitting the paper to PubMed Central.

Thank you for the opportunity to comment. Roberto Peccei UCLA Vice Chancellor for Research

Question 1: The descriptive information about PMC explains that PMC is not intended to replace the original publication of the journal article, rather to archive them and make them accessible in a particular way. The integrity of the contents then continues to rely on the editorial selection processes, peer-review processes, and to some extent on the editorial and production work provided by the journal editorial advisors and on the publishers. In order to present PMC readers with complete information about each article, we recommend that PMC incorporate the name of each journal’s publisher in the primary citation of each article. Publishers should be offered the opportunity to provide a link through which readers could access the journal’s and publisher’s editorial policies, peer-review standards, and funding sources.

We are aware of a proposal for an alternative implementation of the Public Access Policy, where NIH would act as a dark archive and provide links to publishers’ web sites. This proposal would NOT achieve a major goal of the NIH, which is to provide a free, digital and permanent stable archive of biomedical and life sciences journal literature. For a database to be effectively curated and for the quality of material it contains preserved, it must be used regularly. Libraries have a long history in dealing with archiving and preservation issues. We can say emphatically that a dark archive that links to publishers’ web sites is an unacceptable alternative to PMC that NIH has consistently and wisely rejected. Arizona State University fully supports the NIH Public Access Policy in its current form, and commends the NIH’s extensive efforts to seek input from the full range of stakeholders. ASU also supports the efforts of all to move to implement this congressionally approved policy. This policy is supportive of our institution’s and higher education’s commitment to making the results of scientific inquiry available as well as enabling the building on the discoveries of others to enhance understanding. Simply put, the public, as the funding source of this research, is entitled to have free access to the discoveries. One of ASU’s faculty members commented, “I think NIH’s recent policy of open-access to research results is long overdue.”

Several parts of ASU worked together to insure our ability to comply with this mandate. The Office of the Vice President for Research and Economic Affairs communicated multiple times with faculty members already receiving support and has established a mechanism for timely reminders to researchers of the requirement to deposit. This office worked with the University Libraries to develop useful web pages. Both of these units encouraged researchers to become familiar with the requirements of the mandate and a webinar on the topic was well-attended. The Office of General Counsel advised all of us on the issues of copyright management.

There is mixed opinion at ASU regarding a six month or one-year embargo. However, it is the case that journals would not be cancelled at ASU for the reason that articles are available in open access repositories. The pace of science renders ASU faculty members less competitive when subscriptions are canceled. It was further noted by a faculty member that publisher archives are “more tidy” than the current PUBMED Central.

It would be useful if NIH would maintain a list of publishers whose author publishing agreements are consistent with deposit to PMC, without additional copyright addendums. This enables faculty members to “do science” and not be troubled by bureaucracy.

Question 2: In light of the change in law that makes NIH’s public access policy mandatory, do you have recommendations for monitoring and ensuring compliance with the NIH Public Access Policy?

Recognize that it is difficult for institutions to monitor compliance with this policy. Manuscripts and articles are written and submitted by the principal investigator. The sponsored projects office does not get involved in this process. A potential way to monitor compliance is to have NIH ensure that all NIH grant application forms or electronic submission sites include a prompt or field for inclusion of the PMCID on the PI’s cited references that fall within the policy. Perhaps a routine communication process with campus offices of research could be established to ensure compliance.

We recommend advice for researchers who encounter one-click copyright agreements during article submission.

Developing an automated system for alerting institutions when an article has been submitted would be a terrific way to allow institutions to track the submission. Additionally we would like to harvest or be sent the metadata to place in a local repository to link to research generated at our institution-specific, searchable record of compliance and success in publishing research results.

Advice for researchers who encounter one-click copyright agreements during article submission should be made available.

PMC should develop the functionality to identify how many times a particular article has been accessed in order to add to the growing evidence of increased use of publicly accessible research.

Question 3: Enhanced and updated FAQs and current information on the NIH Public Access site to help keep researchers well informed.

Update and maintain lists of journals that comply with NIH policy and that do not charge a fee.

Advice directed to publishers.

Question 4: These comments were prepared by Beth H. Israel, Associate Vice President for Research Administration and Sherrie Schmidt, University Librarian in consultation with ASU faculty members.

Question 1: Our NIH-funded researchers are concerned about proper citation of their work. They would prefer to submit the final published version of articles to assure that PubMed Central (PMC) has the most canonical and easily cited form. It would be reassuring to our authors if the NIH policy stated clearly that they had the option of submitting the final published version of their article, if the publisher were in agreement. It is desirable to include the full citation to the published form, but if readers do not have access to the published form they will be under the impression that PMC has only a preliminary or less authoritative version of the article.

It has been suggested that this policy would harm journal publishers and lead to the cancelation of STM journals. This is a misunderstanding of the decision process in libraries for journal selection. Scholarly journals are typically subscribed within packages, and it is not possible to establish a correlation between individual NIH-funded articles in open access repositories such as PMC and journal cost. Furthermore, libraries are unable to predict which journals will publish NIH-funded articles, so this factor would be a specious one on which to base journal acquisition. Finally, even if the embargo period were reduced to six months, this period would be too long to make the unavailability of the journal a palatable option. We have never used public access availability as a criterion for journal cancelation.

Question 2: We have invested considerably to ensure that Rutgers scholars comply with the requirements of the current legislation. The libraries have played a lead role in formulating university policies on copyright and ensuring that scholars and library services conscientiously observe copyright. Copyright education needs to be a part of every institution’s compliance with the policy. It is to the benefit of both authors and publishers that this conversation takes place. The NIH Open Access policy has enabled our education efforts as no other event has before.

We believe the rate of compliance would benefit from two developments: 1) having the final PMC version of an article sent for verification to both the principle investigator and the lead author listed on the article and accepting verification from one or the other, and 2) developing a strategy for working with publishers which use click through licenses that allow no negotiation.

Question 3: We appreciate all of NIH’s efforts to date to disseminate information and to communicate in a timely manner. We urge continued updating of the FAQ’s and other website information as well as broad announcement of changes and progress.

Question 4: The Rutgers University Libraries appreciate the intention of Congress and the NIH to ensure that the results of publicly funded research be made available to the public. This goal is close to our hearts as the largest public research university in New Jersey, one of the states whose citizens contribute more in taxes to the federal budget than they receive in federal contributions.

We require that submission to our institutional repository include actual content -- not links -- because that is the function of the repository. By analogy, NIH/PMC should have the same requirement. Mere citations with links to the actual content on the publisher’s website, or a “dark archive,” will not fulfill the purpose of the policy. Furthermore, it assigns part of the responsibility for access to publicly-funded research to a private entity. Additionally, to further the wide availability of this valuable content, we urge development of methods of interoperability for exchange of content between PMC and institutional repositories.

These comments are submitted on behalf of the Rutgers University Libraries by Rhonda Marker, Jim Neissen, and Jeanne Boyle.

05/30/2008 at 04:19:35 PM

Hirtle

Peter

M.A., M.L.S.

Cornell University

Ithaca

NY

USA

Other Member of the Public

Question 1: NIH should require that the version of the research as published, and not the author's final manuscript, should be submitted. In my discussions with faculty at Cornell University, they almost always want their best work - the published version of the paper - to be what is read and cited.

I see two ways this could happen. One, NIH could just require that researchers submit NIH-funded research to journals that allow the published version to be available through NIH. There would be no copyright or ownership issues associated with this, since journals that will not allow the published version to be distributed by NIH would be off limits to NIH researchers.

Alternatively, NIH could encourage the use of paid Open Access publishing alternatives. Researchers here are reluctant, however, to use existing grant funds to pay the Open Access charges of major publishers. While grantees recognize that their existing grant funds can be used to pay open access fee, the grant funds they receive are never enough to pay for the work that needs to be done under the grant. Most are therefore reluctant to divert any of the funding to publication costs. Grantees are also worried that including publication costs in proposed grants would make their grants appear to be expensive and less competitive.

A solution would be for NIH to implement a separate fund upon which PIs can draw to pay open access fees from publishers. Such a fund would also save NIH money in the long run since institutions would not be claiming Facilities and Administrative (F&A) costs on grant funds devoted to publication.

Question 1: - NIH should negotiate additional agreements with journals to allow authors to deposit their author's final version, and publicize the list along with the one in submit_process_journals.htm - Embargo period should be decreased - NIH should set up improved notification and communications tools between PMC and other systems - NIH should not consider major changes to current implementation

Question 3: - Easy mechanisms for grantee institutions to receive notification of all items submitted by their faculty in compliance with the Public Access Policy.

See response to Q4 for expansion.

Question 4: The University of Oregon Libraries are very enthusiastic supporters of the NIH Public Access Policy as currently implemented. We have found that implementation costs were low, that short-term side benefits were high, and that long term there is significant enthusiasm among our faculty for the larger public access goals. We have also been very appreciative of NIH willingness to engage all stakeholders, both through public comments such as this and through responses to questions and concerns posted to the NIH website; we have received very rapid and informative responses to questions we have posed.

The University of Oregon has invested significant resources in implementing the Public Access Policy. The implementation brought together stakeholders from across campus who do not normally interact, including our library, office of technology transfer, research and sponsored activities, research institutes, and most importantly our research faculty. It has been part of, and a driving force behind, a library initiative to create a new department of “Scholarly Communications and Instructional Support.” We have begun to build a better database of faculty publications, organized training sessions for librarians and research faculty, developed template copyright transfer addenda that retain the rights necessary to comply with the Public Access mandate, and are developing instructional materials for faculty. The mandate was also the major focus of a UO Faculty Senate subcommittee on authors’ rights.

The policy has been particularly beneficial in encouraging research faculty to engage in thinking critically about scholarly communications, copyright, and authors’ rights. We note that the public law required implementation consistent with copyright law. We feel that the policy has achieved that goal admirably, simply by forcing faculty members to become more aware of their rights and responsibilities under the law. We even suspect that it is increasing compliance with copyright law among faculty who aren’t directly affected by the policy since it has raised awareness by faculty who had engaged in uses of the works they originally authored that were arguably in violation of the copyright they transferred to the publisher.

We are aware that some publishers have expressed concern about the Public Access policy, and believe that concern is misguided. We see no evidence that public access would undermine commercial publishers. Quite to the contrary, the citations to commercial publishers that appear in PubMed Central are free advertising for those publishers, who continue to maintain the copy of record for the published works and through an embargo period continue to have a safeguarded period in which they are providing exclusive access to the information. The evidence is accumulating that providing open access through a repository like PubMed Central increases the visibility and impact of a paper and hence the prestige of the journal in which it is published. By increasing the citation rate and hence the impact factor of the journal, deposit in Pub Med Central increases the probability that our library will continue to subscribe to the journal. Our initial perceptions as a library are that the Public Access Policy is having no impact on journal subscriptions, though we hypothesize a positive impact (increased investment in highly visible journals) in the future.

Interestingly, it appears that the implementation of Pub Med Central has also increased the willingness of our faculty to accept embargo periods for their publications, a common request from commercial publishers. In February of this year our faculty Senate passed a resolution encouraging faculty members to use an author’s addendum to insure that they would retain the rights they needed to their work when they transferred copyright. The general consensus at the time was that the SPARC “Access-Reuse” addendum was most appropriate. Largely in response to the Public Access Policy, our Senate modified its recommendation, and in May recommended that faculty members use the “delayed access” addendum that mirrors the Public Access Policy in granting publishers an embargo period.

As we look ahead to evolution of the policy, we are concerned that some have called for an alternative to the Public Access Policy in which NIH would create a dark archive. Such an archive would not be maintainable; if a database like this is not used regularly it will not be effectively maintained and preserved. It would not increase the visibility of the research, and hence would not accomplish one of the important benefits of the current Public Access Policy – accelerating access and hence the pace of research and new discoveries. In addition, a dark archive would fail to meet the crucial public policy goal of providing easy public access to medical research by the ordinary citizens whose tax dollars fund that research.

For the typical researcher, navigating the complexity of copyright law is the hardest part of complying with the Public Access Mandate. Compliance is made much easier by the large list of journals with whom NIH has negotiated agreements to handle deposit on behalf of the author; this list should be expanded. In addition, it would be very helpful if NIH were to negotiate with other journals agreements that granted authors the right to deposit their author’s final version, and then publicized that list as well.

Another change to the current policy that would be desirable would be a shortened maximum embargo period, perhaps to 6 months. The NIH embargo period is likely to become a standard for other uses of academic works, and a standard period that has broad consensus is particularly desirable. Many of our faculty prefer no embargo period, but could be comfortable with a 6 month period, which is also consistent with the widely used Science Commons delayed access author’s addendum.

Also, it would be very desirable to improve notification of the availability of items in PubMed Central. It should be easy for an university office of research to subscribe to an RSS feed and receive alerts for all new items deposited from their institution, and easy to coordinate PubMed Central with other repositories, including support for automated transfers using OAI-PMH. To aid monitoring of compliance as well as to increase visibility, NIH electronic forms should be modified to include required fields for PMCID as appropriate in citations. It would also be very desirable for the major bibliographical standards such as APA Format and Science format to mandate the inclusion of a PMCID in references if one exists.

The goal of a research university such as the University of Oregon is primarily the creation and conveyance of knowledge. As a public university, we have a particularly strong duty to provide that service for the general public. The Public Access Policy furthers that mission.

Dear Dr Zerhouni, Re: National Institutes of Health (NIH) Mandatory Public Access Policy I am writing on behalf of the Federation of European Biochemistry Societies (FEBS) in response to a request for information (RFI) in the Federal Register, seeking public comment on the NIH Mandatory Public Access Policy. FEBS provides dedicated focal points for its vast network of members in molecular biology and promotes excellence in the molecular life sciences in Europe, through an extended programme of activities, ranging from fellowships, courses and workshops, conferences and scientific publications. FEBS is a not-for-profit scientific organization. Whilst our organization supports the principle of public access to government-funded research and efforts made to enhance public access to science, we have significant concerns about the impact of the public access policy. The policy will affect all stakeholders in the scientific research community but it is likely to have a particularly severe impact on societies such as ourselves, who rely on subscription revenue derived from our journal operations to fund the activities outlined above. We believe that the NIH policy must be implemented in a way that maximizes its effectiveness to the public and the scientific research community, whilst maintaining our journals and Societies. Importance of peer review Our organization believes strongly in high-quality journals as a means of ‘sorting the wheat from the chaff’, where readers can be sure that only the best studies have been accepted for publication. Our editorial boards consist of scientists who have demonstrated experimental insight and expertise in their own field and offer a fair and thorough peer-review of submitted manuscripts. In fields of research heavily dependent on experimental findings the quality of the data and the understanding of the limitations that need to be applied to its interpretation require review by scientists who are themselves intimately involved with these same techniques and are crucial to having the findings widely accepted by those in the field. In short, journals add considerable value by performing peer review. The effort and expense of this process is supported entirely by journals and not the NIH. It is a vital service for science and it is imperative that such a system of expert filtering continues. As subscription revenues decline alongside the free availability of these peer-reviewed manuscripts on PMC there is a real risk that the funds supporting the editorial costs of peer-review (funding the electronic editorial office and financial support of editors) will disappear. Infrastructure In the same way that learned societies act as experts in peer review, it is the active collaboration of our publishers which has aided the efficient transmission of the findings of research to others. This collaboration between experts in science and experts in communication is the principle element in making experimental data, interpretation and analysis available to other researchers world-wide. Just as our Societies’ income derived from our journal operations is fed back into science, publisher profits fund online developments. Once such example is Cross Ref where publishers have collaborated on this initiative bringing about great value to researchers. The notion that secure archiving and continued evolution can be delivered without the involvement of professional publishers who have developed this system seems to defy reason. In an ‘open access’ environment will repositories provide the infrastructure currently offered and continue the evolution of this scientific information process? Quality control In addition to undertaking the marketing, distribution and preservation of our journals, our publishers ensure that copyright protections are maintained, take action against piracy and protect authors’ copyright interests. How will the NIH ensure that the policy respects the integrity of the copyrighted content? We feel that subscription-based publishing has succeeded in providing quality assurance, and it important that the journal sites maintain the final published version which authors should cite. As such, NIH should link the accepted manuscript versions on PMC to the definitive published version on the journal sites (via the DOI) as a version of record.

On a final note, how is NIH planning to continue the dialogue with stakeholders? We would be keen to learn further how the policy develops and to see if our concerns might be addressed. Yours sincerely, Prof. Félix M. Goñi, Chairman, Publications Committee, FEBS

Question 2: See our letter under "Question 1".

Question 3: See our letter under "Question 1".

Question 4: See our letter under "Question 1".

05/30/2008 at 03:15:25 PM

Becker

Mila

JD

American Society of Hematology

Washington

DC

USA

Other Member of the Public

Question 1: In 2006, the American Society of Hematology (ASH) developed an agreement with the National Institutes of Health (NIH) creating a new option for its journal, Blood, to comply with the NIH policy on enhanced access. All Blood authors who published NIH-funded articles from May 2005 forward have no obligation to submit manuscripts to the NIH archive because Blood does this on their behalf. The PMC (NIH Portfolio) Archive Program was the result of efforts by ASH and a group of nonprofit publishers to improve compliance with the voluntary NIH public access policy while maintaining the publisher-mandated access embargoes.

The PMC (NIH Portfolio) Archive Program has the following terms: The participating project provides NIH with final articles representing NIH-funded research. NIH has internal use of the articles during participating journals’ embargo period, which can be no longer than 12 months. During the embargo period, NIH can link to the journal web sites to provide access to NIH-funded research articles; following the embargo period, NIH can provide links to the journal, but can also distribute articles directly from its PMC web site (NIH’s view of an article includes a page banner that identifies the corresponding journal and provides a link to the journal’s own web site). ASH volunteered to have Blood be the first participant in the program and agreed to provide articles going back to the original May 2005 implementation date of the original NIH Public Access Policy.

ASH has implemented the PMC (NIH Portfolio) Archive Program for almost two years, and the Society strongly believes that this option meets the NIH Public Access Policy goals while providing a better alternative for journals and authors than the newly mandated policy. Consequently, ASH’s comments below focus on the importance of maintaining this option and promoting participation in it to other nonprofit publishers. ASH strongly believes that the PMC (NIH Portfolio) Archive Program provides a better alternative for journals and authors than the newly mandated policy. Through this option, NIH obtains one hundred percent compliance in the policy by participating journals because the journals submit to NIH the final version of NIH funded research articles upon publication on behalf of their authors. NIH also has the ability to create a stable archive of peer-reviewed research publications resulting from NIH-funded research and a secure searchable compendium of these peer-reviewed research publications that NIH can use to manage research portfolios and set research priorities. In addition, this program protects the integrity of journal articles by allowing the journal to submit the final article, maintains journal business models by protecting the embargo period and the peer-review system, and, importantly, continues to allow enhanced access of science to researchers and the public. ASH believes NIH should take steps to increase its outreach to other nonprofit publishers to promote participation in this program.

Question 2: The American Society of Hematology (ASH) strongly believes that the PMC (NIH Portfolio) Archive Program provides a better alternative for journals and authors than the newly mandated policy. Through this option, NIH obtains one hundred percent compliance in the policy by participating journals because the journals submit to NIH the final version of NIH funded research articles upon publication on behalf of their authors. NIH also has the ability to create a stable archive of peer-reviewed research publications resulting from NIH-funded research and a secure searchable compendium of these peer-reviewed research publications that NIH can use to manage research portfolios and set research priorities. In addition, this program protects the integrity of journal articles by allowing the journal to submit the final article, maintains journal business models by protecting the embargo period and the peer-review system, and, importantly, continues to allow enhanced access of science to researchers and the public. ASH believes NIH should take steps to increase its outreach to other nonprofit publishers to promote participation in this program.

Question 3: The American Society of Hematology (ASH) has several comments related to the information and responses provided in the Frequently Asked Questions material posted at http://publicaccess.nih.gov/FAQ.htm#content. They are as follows: Section A-General Information - The information provided to question 1 states, “It [NIH Public Access Policy] requires scientists to submit journal articles that arise from NIH funds to the digital archive PubMed Central.” ASH recommends that this information reference that scientists are required to submit or publish in a journal that will submit on their behalf. In this way, NIH acknowledges upfront the option of the PMC (NIH Portfolio) Archive Program. The Society believes that researcher authors may want to eliminate the burden of submitting their articles to NIH and may be attracted to submitting their articles that will provide this service for them.

Section B-Scope of the Policy - The information provided in response to question 2 states, “The Policy applies to all peer-reviewed journal articles, including research reports and reviews. The Policy does not apply to non-peer-reviewed materials such as correspondence, book chapters, and editorials.” It has come to the Society’s attention, however, that several non-peer-reviewed materials have been submitted and posted to PMC. Therefore, ASH urges NIH to make sure implementation of the Policy is consistent with this response.

The information provided in response to question 4 concerns whether submission is required for research funded by a grant or cooperative agreement that expired before FY 2008. ASH recommends that NIH include in this response that the author should check with the journal to make sure the submission is not duplicative, if he or she decides to submit.

Section C-How to Comply With the Policy – ASH is pleased that NIH has included in the response to question 1 that some publishers have agreed to make the final published article of every NIH-funded article publicly available in PubMed Central within 12 months of publication and for these journals, authors do not need to do anything to fulfill the submission requirement. The Society recommends, however, that this language also be included prominently upfront in the General Information section as well in order to make sure authors are aware of this option and to prevent duplication of submission or incorrect submission by well-intended authors.

ASH is also pleased that NIH notes in response to question 2 that authors should work with the publisher before any rights are transferred to ensure that all conditions of the NIH Public Access Policy can be met. It is critical that authors be encouraged to work with their publishers in order to meet the requirements of the NIH Public Access Policy and also the requirements of the publisher. Similarly, ASH recommends that in response to question 3 concerning language for the copyright agreement, NIH should refer authors back to their publishers to ensure that the authors adhere to the publishers’ requirements and legal counsel. On this point, ASH is particularly concerned that NIH intramural investigators recently were instructed to only use the NIH publishing agreement, not accept a publisher’s copyright transfer agreement, and to submit their manuscript (not final article) to PubMed Central upon acceptance. Further, the recent instructions to intramural researchers state that if the journal rejects the NIH Publishing Agreement or wants to change it, the author must recall the manuscript and submit it to another journal. These instructions are not only inconsistent with the Public Access FAQ, but they undermine the terms of the PMC (NIH Portfolio) Archive Program. ASH believes that if an article is based on NIH-funded research by a NIH intramural researcher the information is in the public domain. Legally, therefore, the intramural researcher author cannot assign copyright to ASH or to the NIH. ASH would like to discuss this more thoroughly with NIH to resolve issues raised in these instructions following the Request for Information comment period.

Question 1: The Association of College and Research Libraries (ACRL), a division of the American Library Association (ALA), represents more than 13,000 academic and research librarians and interested individuals. ACRL has long supported the National Institutes of Health’s Public Access Policy, believing that ensuring public access to the fruits of publicly-funded research is a logical, feasible, and widely beneficial goal. We appreciate NIH’s continued, consistent willingness to engage with stakeholders. These comments supplement the ones we submitted this past March.

ACRL reiterates its support for the policy as it stands. Public access to publicly funded biomedical research will advance research and education at the nation's colleges and universities, helping undergraduates, graduate students, faculty, and researchers remain competitive with their peers elsewhere in the world. Research in the biomedical sciences advances rapidly, and 12 months, as stipulated in the current policy, is the longest period for which this research should be embargoed if the benefits of public access for education and research are to be realized and our colleges and universities remain globally competitive.

Evidence continues to build that the cost of validating, packaging, and disseminating research results can be met through a variety of business models that are consistent with public access. Public access to selected articles is not the primary determinant for most libraries in making subscription decisions -- relevance, quality, and affordable pricing are the key factors. Indeed, a shorter embargo period (6 months) would bring US policy into greater alignment with policies already in place in Canada, the UK, and the European Union, and would better reflect the rapid pace of research in the biomedical fields. We encourage the NIH to consider shortening the embargo period as the U.S. and other countries gain experience with public-access science.

Moreover, we understand that the current policy operates within and in accordance with U.S. copyright law and international copyright conventions, and is consistent with the authors' rights in their original manuscripts. Implementation of this policy on member campuses is providing an important opportunity for those communities to discuss intellectual property law and compliance. ACRL has supported member education in this area by, for example, co-hosting (with ARL and SPARC) a special one-hour Webcast for librarians called “Understanding Author Rights.”

Academic and research libraries across the country have already invested significant time in helping their campuses prepare for and implement the new policy, through outreach, copyright education, technical support, and other means. ACRL, guided in part by its Scholarly Communication Committee, will continue to assist its members with implementation of the policy by, for example, documenting and sharing best practices, promulgating model publication agreements, and providing education about the rapidly changing scholarly publishing environment in which this policy fits. The ARL-ACRL Institute on Scholarly Communication and a new shorter workshop on scholarly communication, currently in development, both cover the NIH policy.

Alternative arrangements, such as links to publishers' web sites, would not serve the public well or achieve the NIH goal of assuring a permanent, stable public archive of the research it has funded. Over the long term, as publishers and journals change ownership, links would inevitably break and more work would be required of NIH staff to maintain the links than would be needed to maintain a central repository. Advanced researchers will still rely on the published record for citation and other purposes. NIH has wisely rejected the model of a dark archive in the past, and should continue to do so.

Question 2: Individual campuses are in the best position to explain their needs and circumstances with respect to encouraging and monitoring compliance with the new policy. However, ACRL encourages the NIH to work with campuses on two fronts:

First, establishing routine communication with campus offices of research. These are the campus entities best positioned to ensure consistent, timely communication with investigators who might be planning an NIH grant application. Increasingly, campus offices of research are collaborating with their university libraries to help investigators understand the policy and comply with it, and NIH might consider encouraging such collaboration where appropriate.

Second, collaborating with the institutional repository community -- and with individual campuses that maintain open repositories of the scholarship of their faculty and students -- to identify ways to coordinate manuscript deposit between PubMed Central and institutional repositories, possibly in batch uploads or downloads.

05/30/2008 at 02:41:48 PM

Giesecke

Joan

Doctorate

University of Nebraska-Lincoln

Lincoln

Nebraska

USA

Other

Question 1: At the University of Nebraska-Lincoln we have developed a simple, cost effective system to alert faculty to the deposit requirement and have provided resources in the library to assit eith or to deposit publications for the faculty. We have found that so far faculty are publishing in journals where the publisher is depositing the article in PubMed for the authors. The process of depositing papers in Pub MEd is not impacting the decision of the library to purchase any given journal title.

Question 2: Anything NIH can do to notify the campus research compliance office when an article is deposited would be helpful. While the faculty will be notified, it will help campus accounting to have the information directly from NIH.

Question 3: Continuing updates on which journals will deposit in PubMEd for the author is greatly appreciated.

Question 4: This policy is helping to make NIH funded resaerch more readily available. It is not impacting our decisions on which journals to purchase. It has not created a work load problem as we incorporated the requirement into already established campus procedures.

Question 1: The Association of Learned and Professional Society Publishers (ALPSP) is the international association for non-profit publishers and those that work with them. ALPSP is the only international association that represents scholarly and professional publishers across all disciplines of academic endeavour. Its broad and diverse membership includes publishers of journals operating on author-side payment models, subscription models and hybrid business models combining these. ALPSP has more than 360 organizational members including more than 40 in the United States. We have members in 36 countries who collectively publish more than 10,000 journals – around half the world’s total - as well as books, databases and other resources. ALPSP’s mission is to play an active part in shaping the future of academic and scholarly communication, and we welcome the opportunity given by the National Institutes of Health to comment on the ‘Revised Policy on Enhancing Public Access to Archived Publications Resulting from NIH-Funded Research’ (NOT-OD-08-057) (Revised Policy) by responding to the ‘Request for Information: NIH Public Access Policy’ (NOT-OD-08-060).

This submission will only comment on those questions which we consider relevant to the ALPSP membership.

Many journal publishers, and most of those publishing in the biomedical sciences, make the final ‘version of record’ journal article freely available on the Internet a maximum of 12 months after publication. We believe that it would be highly preferable if NIH linked PubMed and/or PubMed Central to final published journal articles on publishers’ website and adapted PubMed and PubMed Central to allow for full-text searching across the publishers’ websites.

This approach does not constitute a “dark archive” as some have suggested since articles appearing in journals operating a delayed open access publishing model are available freely on the Internet in compliance with the NIH public access requirement. We would suggest that the policy mandating deposit of peer-reviewed manuscripts in PubMed Central should be reserved for only those articles published in journals that do not make content freely available on the publishers website after 12 months or less.

There are numerous advantages to this approach: * It would provide a more comprehensive ‘one-stop-shop’ for searching the biomedical literature which would include vastly more than the 10% of articles that arise from NIH funded research * It would assist with version control and enable readers to access the trustworthy version of record with corrections, links to corrigenda and errata and thus maintain the integrity of the corpus of literature * Journals would be able to determine their own access policies within a 12 month timeframe based upon the requirements of their business models * It would eliminate needless and expensive duplication of the storage, curation and preservation of a large number of research articles

We therefore urge NIH to reconsider this proposal.

We note the confusion that has arisen from the use of the term “journal articles” in the Public Access Frequently Asked Questions (FAQs) posted on January 11, 2008 and the continued use of the terms “journal manuscripts” and “journal papers” used in the amended version of the FAQs (http://publicaccess.nih.gov/FAQ.htm) as updated on May 2, 2008. We believe that NIH should be clear and unambiguous in referring to the final peer-reviewed manuscript in order to avoid confusion with the final journal version of record.

We would draw your attention to the NISO / ALPSP project on Journal Article Versions (see http://www.niso.org/workrooms/jav) which will shortly produce a standard nomenclature for versions of journal articles. We urge NIH to utilize these definitions once the standard has been formally announced by NISO.

We note that Congress directed the NIH to ensure copyright agreements and rights were preserved and it seems onerous, unfair and an avoidance of this responsibility to transfer that obligation to researchers. At the very least the NIH should implement procedures during the process of uploading manuscripts to PubMed Central to check that the version of the article uploaded is consistent with copyright law and that institutions and investigators are complying with their obligation to ensure that “any publishing or copyright agreements concerning submitted articles fully comply with this Policy”.

The Revised Policy now calls for the deposit of review articles. Review articles are commissioned by Publishers and Editors and are written based on the scientific expertise of the author; they are not based on the specific research projects supported by NIH grants and we therefore respectfully suggest that review articles should not be subject to the mandatory Revised Policy.

Question 2: As mentioned in above, ALPSP believes that NIH should implement measures to ensure that manuscripts deposited in Pub Med Central in response to the Revised Policy are the correct version and that the Revised Policy is therefore implemented in a manner consistent with journal policies and copyright law.

To assist with version control, adherence to copyright law and to minimize duplication of costs, NIH should implement measures to ensure that where manuscripts are deposited by journals on behalf of their authors the submission of duplicate copies or different versions are not accepted for ingress into PubMed Central.

We believe that NIH should implement measures to detect inappropriate usage of manuscripts and other copyrighted material posted on PubMed Central and should immediately alert the publisher of any articles so abused. NIH should also implement specific safeguards to prevent copyrighted material available on PubMed Central from being altered, pirated, made into derivative works, redisplayed, republished, resold or used for any other commercial purpose.

Question 3: ALPSP fully supports the thorough list of concerns regarding the NIH public access policy and its implementation advanced by the Professional and Scholarly Publishing Division of the Association of American Publishers and the DC Principles Coalition. These questions were raised in a letter (see www.dcprinciples.org/Zehouni-4-16-08.pdf) to Dr E A Zerhouni on April 16, 2008 and are repeated below for your convenience.

Questions / comments raised by Professional and Scholarly Publishing Division of the Association of American Publishers and the DC Principles Coalition

1) Regarding Consultation with Publishers, Societies and Authors

• Many investigators are not aware of the new policy. Does NIH have a formal mechanism and the necessary resources to handle the questions that will arise from authors and journals? • What is NIH’s timeline for amending this policy moving forward? • What mechanism will NIH put in place to continue the dialogue with publishers that will help ensure this policy is “implemented and steered” effectively and that publisher concerns are addressed?

2) Regarding Copyright

• Why hasn’t the NIH supported the full value of copyright and its use in business models including those which involve driving traffic to a publisher site, and permit linking to publishers’ web sites, rather than requiring deposit at PubMed Central?

3) Regarding Brand Protection, Repurposing and Piracy

• What mechanisms will NIH put in place to ensure that any revisions to copyrighted materials such as reformatting, enhancing, linking or otherwise changing the articles respect the integrity of the copyrighted content it receives? What assurance will NIH give that this will be done in accordance with guidelines agreed to with publishers? • Will NIH identify precisely how manuscripts will be linked to databases and other resources, and which databases? Publisher concerns about links include: a) would links within the article obscure the information in the text? b) Would it change the editorial emphasis by seeming to suggest that certain information within the article is more important than other information, simply because there is a link? c) Would it be appropriate to change that emphasis in the context of the research and the article’s focus? • How will NIH ensure proper protection of publisher or society trademarks and branding? There been no affirmation of these markers of quality, and often branding information is missing, potentially misleading users to the erroneous conclusion that the NIH is claiming copyright, or that the content is in the public domain. • How will NIH respect the rights of copyright holders and stipulate what NIH will or will not allow related to third-party use of its works? Will NIH, for example, ensure that manuscripts are not distributed to other sites around the world besides PubMed Central? Will NIH implement guidelines that explicitly prohibit third parties from exploiting content that appears on PMC without the consent of the publisher? • How will NIH prevent piracy of the articles from PubMed Central? Will NIH prevent copyrighted material available on PMC from being altered, pirated, made into derivative works, redisplayed, republished, resold or used for any other commercial purpose? What will happen if piracy is discovered as a result of downloading of content from PubMed Central and will NIH notify publishers? • If deposited content will be “mirrored” to other sites outside the U.S., after publisher approval, how will the sites be established, and how would national and international copyright considerations protect rights holders? What guidelines will NIH agree to with publishers before any distribution of copyrighted content occurs on PMC international mirror sites?

4) Regarding Compensation

• What latitude will NIH have in negotiating terms and conditions directly with publishers and other rightsholders who might wish to undertake direct licensing arrangements with NIH that would enable the deposit of copyrighted works on behalf of authors? Given that NIH’s policy would amend many journal copyright policies and effectively reduce the value of those rights, will NIH be empowered to negotiate such licensing terms, including publication charges/payment, as certain non-government funding agencies have done? • The policy provides for publisher deposit of final peer-reviewed manuscripts on behalf of authors, and includes allowance for grantees to use grant funds in the payment of publication fees. How will such funds be identified in the grant and what has NIH budgeted per year for such costs over the next five years?

5) Regarding Scope

• If other public or private funders support research also supported by NIH, what will researchers be expected to do if these other sources oppose the posting of their funded work on PubMed Central? • Will NIH agree to stipulate that its requirement for the deposit of peer-reviewed manuscripts in PubMed Central only applies when NIH funding represents substantial funding for the research on which the scholarly work is based? • The policy also holds that “Principal investigators and their institutions are responsible for ensuring all terms and conditions of awards are met.” Yet, this includes the submission of articles that arise directly from the investigators’ NIH-funded research even if they did not author or co-author the publication. In fact, NIH-funded investigators and institutions are being held responsible for making sure these other authors are “aware of and comply with” the NIH policy. How could they comply with this provision? • What will the repercussions be for investigators and journals that do not follow the process? • NIH’s 2005 voluntary policy stated that it did “not apply to contributed book chapters, editorials, reviews, or conference proceedings.” Rather, it applied “only to peer-reviewed research publications.” Will NIH modify its guidelines to state that its deposit requirement only applies to peer-reviewed manuscripts that report findings of empirical research and does not apply to literature reviews?

6) Regarding Integrity of Research, Quality Control and Meaningful Public Access

• How will the NIH know the final month of publication when the month is not always established upon acceptance to a journal? • Many manuscripts currently appear on PMC in violation of publisher policies. How will NIH ensure under the new public access policy that individuals post the correct manuscript version to PMC to be publicly available at the correct time, consistent with publisher agreements? Will NIH ensure that embargo and posting policies are implemented on a journal-by-journal level or at least publisher-level? Will NIH provide a detailed description of the process at NIH to monitor and ensure prompt take-down of manuscripts improperly submitted? • For publishers submitting directly, how will NIH ensure that manuscripts will not be accepted from individuals or entities other than the publisher? • How will NIH ensure that researchers are not misled as to the accuracy and validity of manuscripts on PMC? Will there be pointers to final published versions on publisher sites? Will NIH develop, for example, a special section within PMC for members of the general public/patients to “land” on suitable information for patients and “disclaimers” that the PMC author manuscript represents only a small part of the literature, with references and links to voluntary health organizations (VHOs), Patient Inform, publisher sites? • How will NIH deal with plagiarism and ethics issues? Will NIH establish guidelines in consultation with publishers on how to deal with corrective notices, corrigendum, and retractions?

7) Regarding Cost

• NIH faces funding shortages from the federal government. How much will it cost to effectively implement this policy? • Does this cost detract from funds to grantees actually conducting the innovative research that advances science?

8) Regarding Measuring Impact and Effectiveness

• Will NIH provide publishers with detailed and robust PMC bibliographic usage statistics that will enable them to assess the impact of PMC usage on their subscriptions? • What oversight or governance will monitor whether NIH’s performance in pursuit of its intended purpose a) is met; b) is not costly for the taxpayer; c) is not burdensome on research investigators; or d) does not have a negative impact on the integrity of the scientific and medical literature (e.g. errors and versioning problems introduced, economic harm to journals and publishers)? • What steps will NIH take if it is found that its Public Access Policy is hurting rather than advancing scientific research?

Question 4: ALPSP supports the principle of public access to scientific literature but believes that the aims of the NIH public access policy are best met by NIH consulting and working in conjunction with all relevant stakeholders, including publishers, on an ongoing basis and in a robust and meaningful manner.

We believe that by implementing the Revised Policy on April 7, 2008 - before completing a thorough consultation - the approach taken by NIH regarding the Revised Policy does not adhere to the Administrative Procedure Act. We also note the short timescales between the announcement on March 7, 2008 of a public meeting regarding the Revised Policy, the meeting taking place on March 20, 2008 and the Revised Policy coming into effect on April 7, 2008.

We therefore respectfully request that the NIH suspend the Revised Policy and undertake a formal rulemaking according to the provisions of the Administrative Procedure Act. A Rulemaking would allow all interested stakeholders the opportunity to comment with adequate deadlines and offer a formal procedure via which the NIH could address the issues raised.

In addition, we are aware of calls for the NIH to reduce the upper limit of the Revised Policy’s embargo period from 12 months to six months or less. Research (see for example Self-Archiving and Journal Subscriptions: Co-existence or Competition? (Beckett and Inger 2007; www.publishingresearch.net/documents/Self-archiving_summary2.pdf) and ALPSP Survey of Librarians on Factors in Journal Cancellation (Ware 2006; www.alpsp.org)) has indicated that the upper limit of 12 months is the minimum required for publishers of biomedical journals supported by subscription revenues to have a chance of recovering their costs. We therefore urge NIH to commit retaining the upper limit at 12 months and allow journals to choose a shorter embargo period if it is compatible with their business model.

Question 1: The American Institute of Physics (AIP), an umbrella organization for 10 physics-related societies representing 130,000 scientists and engineers and a nonprofit publisher of physics journals, remains concerned about government-mandated public access. We believe that making the results of tax-payer funded research widely available is an important objective that may accelerate scientific discovery and increase the probability that important discoveries will be used in a more timely fashion. Although the intent of public-access policy is laudable, the issues underlying the implementation of this policy are economic and legal, and may result in unintended consequences detrimental to scientific societies.

The reliance on authors to deposit articles is problematic. Publishers want to perform this action on behalf of their authors, but the NIH implementation requirements make this unnecessarily difficult. NIH should form a working group that includes publishers and the NIH representatives to work out the details of implementation.

AIP as publisher retains copyright but grants authors rights to deposit their manuscripts into Pub Med Central (PMC). That permission does not grant NIH the right to provide the manuscripts to other entities, domestic or international, unless agreed to by the publisher. The public law that had created the mandate said nothing about NIH sharing the deposited works with other entities. AIP will consider such actions to be a violation of its copyright and take action to protect its interest. In addition, we ask that NIH ensure all possible measures are taken to eliminate article piracy. Should a piracy occur, publishers are to be notified and provided with any information NIH may have about the infringer.

Furthermore, it should be stated for the record that Congress recently addressed the research-access issue in Title VII of the America COMPETES Act by establishing an access policy to research funded by the National Science Foundation (NSF). In the National Science Foundation Authorization Act, which was signed into law by the President in August 2007 as Title VII of the America COMPETES Act (P.L.110-69), Congress addressed the issue of ensuring public access to the results of government-funded research. The Act directed NSF to make all “final project reports and citations of published research documents” resulting from NSF funded research available to the public in a timely manner and in electronic form through the NSF’s Web site. The Conference agreement (House Report 110-289) further clarified that NSF is required “to provide the public a readily accessible summary of the outcomes of NSF-sponsored projects,” along with “citations to journal publications,” in which funded researchers have published articles regarding such research.

Since the NSF research-access policy was developed by Congress and is now public law, and since NSF funds research for all disciplines (and 20% of all basic research), other Federal research-funding agencies should follow this model in making their research widely available to the public. The NSF research-access model helps meet the important objective of widespread dissemination of research findings without undermining the important intellectual property and copyright protections that help sustain the scientific publishing community.

Who pays for the value-added after an author submits his/her manuscript to a publisher or institutional online platform is an important question that needs to be addressed. Should institutional platforms—such as PMC—be using government funds to reproduce what is already effectively supplied by the private sector? Publishers (both for-profit and nonprofit) invest considerable resources in the editorial and production processes that underlie high-quality journals. The result is high-quality articles that have been peer reviewed, copyedited, and properly referenced to the world’s scientific literature. The articles are then made available in online versions on highly reliable, digital platforms that constantly evolve to meet the changing needs of their readers. They are also published and distributed in print versions—the only form accepted by some archivists and librarians as archival. Publishers who provide this value-added to the submitted manuscripts are compensated for this service under several business models. The models typically involve the reader paying (through institutional or individual subscriptions) or the author paying (through open-access fees or page charges) or a combination of the two. If the NIH public-access policy is implemented without real engagement of the publishing community, the viability of the journal publishing enterprise—a significant asset to the scientific community and valuable means of distribution to the international scientific community—could be adversely affected.

Scientific journals help assure the integrity of science by organizing and managing peer review of scientific manuscripts to guarantee their accuracy as well as publishing, archiving and disseminating the articles. Publishers invest hundreds of millions of dollars each year in the peer-review process that ensures all research articles are rigorously reviewed by experts in specialized fields before they are published. Federal agency research-access policies that would undermine our nation’s scientific enterprise must be avoided.

Question 2: A useful way to minimize the negative unintended consequences of the current mandatory policy would be to establish, maintain and empower a working group of representatives from the publishing community and the NIH to help guide implementation and modifications to the current policy.

Question 3: The previous voluntary policy (2005) failed, in part, because there was no significant collaboration between NIH and publishers of scientific journals, to either optimize the implementation of the policy or to examine the unintended consequences of the policy. To avoid a similar failed implementation this time, NIH should work collaboratively with the publishing community.

Question 4: Although AIP disapproves the NIH implementation of the NIH Public Access Policy, it is so important that the accurate record of scientific progress not be distorted by the appearance of multiple and differing versions of the purported final manuscript that AIP is prepared to bear the full cost involved in handling the deposit of the final published version of the article on behalf of the author. AIP is committed to staying engaged to ensure that improvements are made in the NIH implementation process.

05/30/2008 at 01:59:43 PM

Yeager

Lynn

MLS

University of Oklahoma - Tulsa

Tulsa

OK

United States

Representative NIH Funding Recipient Organization

Question 4: We are aware of a proposal for an alternative implementation of the Public Access Policy, where NIH would act as a dark archive and provide links to publishers' Web sites. This proposal would NOT achieve a major goal of the NIH, which is to provide a permanent, stable archive of its research. For a database to be effectively curated and for the quality of material it contains preserved, it must be used regularly.

Libraries have a long history in dealing with archiving and preservation issues, and can say emphatically that a dark archive that links to publishers’ Web sites is an unacceptable alternative that NIH has consistently and wisely rejected.

05/30/2008 at 01:19:29 PM

Sinn

Robin

MS

Sheridan Libraries; Johns Hopkins University

Baltimore

MD

USA

Other Member of the Public

Question 1: It would be useful to have NIH provide some guidelines for authors dealing with online click through copyright agreements.

Question 2: Not particularly. NIH has been very good about providing opportunities for feedback from everyone involved. If the current procedures don't work, I'm sure NIH will involve everyone in improving those procedures.

Question 3: A way to submit a test manuscript would be nice, so that librarians could demonstrate the full procedure to faculty needing assistance.

Question 4: I am thrilled that this step is being taken. I believe the publishers will not lose money, due to the ability to embargo articles up to 12 months. I believe US taxpayers will be able to see how some of their tax dollars are being spent. Researchers around the globe should benefit since they will have access to research that might not have been available to them previously.

05/30/2008 at 01:13:35 PM

Suber

Peter

Ph.D., J.D.

Earlham College, Yale Law School Information Society Project, SPARC

Brooksville

Maine

USA

Other Member of the Public

Question 1: (A) The NIH should reduce the permissible embargo period to from 12 months to six months. Around the world, every other funder of medical research with a public access policy caps the permissible embargo at six months: the Arthritis Research Campaign (UK), British Heart Foundation, Canadian Breast Cancer Research Alliance, Canadian Institutes of Health Research, European Research Council, Cancer Research UK, Chief Scientist Office of the Scottish Executive Health Department, Department of Health (UK), Fund to Promote Scientific Research (Austria), Genome Canada, Howard Hughes Medical Institute, Joint Information Systems Committee (UK), and the Wellcome Trust (UK). These agencies recognize that delaying public access to publicly-funded research is a compromise with the public interest, and that delays are more harmful in medicine than in any other field.

If reducing the embargo period quickly or suddenly is politically impossible, then the NIH could reduce it gradually. For example, it could announce that a year from now it will reduce the maximum embargo to six months, giving stakeholders time to prepare. Or it could first reduce it to nine months, then six, and then three, over a period of years with ample notice to all.

The NIH mission is to advance medical research and healthcare, not to protect the revenue of publishers. The current embargo period is much too long and inverts these priorities.

(B) PubMed Central should develop the means to harvest copies of the full-text papers it needs from institutional repositories at universities, if it doesn't already have this capability. Then NIH should allow grantees (optionally) to deposit in their local repository and send PMC the URL. This change should not affect the timing of deposits within PMC, the completeness of the PMC collection, or the ability of the NIH to monitor compliance. But it might make compliance easier for authors, by enlisting local help with the initial deposits. It would also build up institutional repositories nationwide, giving them a critical mass and helping them to change expectations in every discipline.

Conversely, PMC should also allow institutional repositories to harvest copies of full-text papers in PMC. When grantees choose to deposit directly into PMC rather than their institutional repository, this would allow the author's institution to maintain a complete, open-access portfolio of its own research output.

(C) NIH already maintains a list of journals willing to submit articles directly to PMC on behalf of authors, http://publicaccess.nih.gov/submit_process_journals.htm

It should also maintain a list of journals whose standard copyright transfer agreements are already consistent with the NIH policy, requiring no negotiation or "author addendum" by authors. This list will overlap with the first, but would very likely be larger.

(D) Some subscription-based journals plan to charge NIH-funded authors a fee for the right to comply with the NIH policy. Some "hybrid" journals may force NIH-authors to "choose" the free-access option and pay the accompanying fee. NIH-funded authors needn't publish in those journals, of course, but some may sincerely believe that every other publisher would also charge such a fee and some may feel other pressures to acquiesce. The NIH cannot directly stop journals from charging such fees, but it should look for creative, indirect ways to deter the practice. For example, NIH could list journals engaged in the practice and inform its grantees that this is not the norm and not required by the NIH policy. In addition, it could decide that it would *not* allow grantees to use grant funds to pay publication fees or color charges at journals engaged in the practice. (To use jargon common in the open access movement, the NIH would still allow grantees to use grant funds to pay for gold OA at full OA journals; but it would not allow the use of grant funds to pay for green OA or to pay for gold OA at hybrid journals which force NIH-funded authors to select the fee-based free-access option.)

Question 3: The NIH already says in many places that deposit is required at the time an article is accepted for publication, not 12 months after publication. But many grantees, universities, and publishers are not getting the message. Can you make this explicit statement in even more places?

Question 4: The new NIH public access policy serves the public interest and is long overdue. It accelerates medical research and promotes the translation of research into clinical practice and new cures. I oppose attempts by the publishing lobby to water it down or interrupt its implementation.

Congress asked for a mandatory policy in 2004, but the NIH adopted a voluntary policy instead. The compliance rate for the voluntary policy ranged from 4% to 15%, and failed to meet the objectives of Congress and the agency. It's no exaggeration to say that we've waited more than three years for the strengthened policy to take effect and exert its beneficial effects on medical research and healthcare. Further delay would further delay those benefits.

Since the strengthened policy was announced in January, and took effect in April, researchers and their institutions throughout the United States have geared up to comply with it. Here's a list of some of the institutions with web pages devoted to their efforts to educate their faculty about the policy and assist them in compliance. http://www.earlham.edu/~peters/fos/newsletter/04-02-08.htm#nih

The policy has been thoroughly vetted. The NIH released its first draft policy for a 60 day period of public comments, ending on November 2, 2004, and later extended the period by two weeks. The agency received more than 6,000 comments, which Director Elias Zerhouni described as "overwhelmingly supportive." The NIH solicited a second set of public comments as recently as March 2008 (the comment period ended March 17, 2008). The current round of public comments is the third. Publishers have been heard. As SPARC documented in its public comment (May 30, 2008), "the Office of the NIH Director has met with publishers to discuss the policy 29 times between 2003 and March 2008, versus 20 meetings with all other stakeholders."

I submitted a shorter version of this comment in the second round of public comments, on March 14, 2008. http://publicaccess.nih.gov/comments/comments_via_email.htm

Publishers are mistaken to say that the policy violates copyright. Indeed, the policy uses a simple, effective method to avoid any question of copyright infringement. When NIH grantees publish articles based on NIH-funded research, they must now retain the right to comply with the public access policy, even if they transfer all their other rights to publishers. As a result, public access by the NIH is expressly authorized by the copyright holders.

The public access policy is badly needed to insure that the large volume of high-quality medical research produced by the NIH is made available to everyone who can make use of it: researchers whose universities cannot afford access to the full range of biomedical journals, practicing physicians without university or large-hospital affiliations, non-profit disease advocacy organizations, and patients and their families.

It's not true that all who need access already have it. The best evidence that free online access to peer-reviewed research meets a large unmet need is that open-access articles are cited 50-250% more often than non-open-access articles published in the same issues of the same journals. For the empirical evidence underlying this claim, see the empirical studies collected in the Hitchcock bibliography, http://opcit.eprints.org/oacitation-biblio.html

It's not true that the rise of free online access to peer-reviewed literature will jeopardize peer review itself. Publishers who make that argument cite no evidence and ignore abundant counter-evidence. For a detailed analysis of the question, see my article from September 2007, http://www.earlham.edu/~peters/fos/newsletter/09-02-07.htm#peerreview

Some publishers have proposed an alternative under which PMC would be a "dark archive" and merely link to the articles at publisher web sites. This proposal is very far from adequate. It does not satisfy the terms laid down Congress and the President, which require that PMC make articles "publicly available". It makes public access depend on publishers, when publishers might change their access policies or go out of business. Publisher delays and omissions would be inevitable; and even when inadvertent, either NIH would spend time and money on monitoring and enforcement, or some valuable NIH-funded research would not be publicly available. Long-term preservation would suffer because libraries and other third-party curators would have to seek permission from many different publishers to make copies for storage and to migrate those copies to new formats to keep them readable as technology changed. Finally, users would fail to get the benefit of the enhancements PMC makes to submitted articles, including XML markup, OAI-interperability, and links to relevant content in the many public NIH databases. Users would be stuck with the publishers' PDFs, which are not readable in bandwidth-poor parts of the world, which frequently lack working links, and which impede text processing by users, text mining and automated translation by software, handicapped access, and mark-up by third parties.

I thank the NIH for its repeatedly demonstrated willingness to take comments from stakeholders.

05/30/2008 at 01:01:38 PM

Michalak

Sarah

MLS

University of North Carolina at Chapel Hill

Chapel Hill

NC

USA

Representative NIH Funding Recipient Organization

Question 1: This comment supplements those we submitted yesterday. We have recently learned of calls for the PubMed Central archive to be made a "dark archive" that links to publisher Web sites. This proposal would not achieve the goal of creating a permanent and stable archive of NIH-funded research and would not enhance access to such research. NIH has wisely rejected this alternative, and we urge NIH to maintain this position.

05/30/2008 at 01:01:08 PM

Michalak

Sarah

MLS

University of North Carolina at Chapel Hill

Chapel Hill

NC

USA

Representative NIH Funding Recipient Organization

Question 1: This comment supplements those we submitted yesterday. We have recently learned of calls for the PubMed Central archive to be made a "dark archive" that links to publisher Web sites. This proposal would not achieve the goal of creating a permanent and stable archive of NIH-funded research and would not enhance access to such research. NIH has wisely rejected this alternative, and we urge NIH to maintain this position.

NIH previously encouraged publishers to add review articles to journals as a way to sustain our subscription base under the voluntary policy. The revised mandatory public access policy now calls for the submission of review articles to PMC. Journal editors commission review articles based on the scientific expertise of scientists; they are not based on specific research projects supported by NIH research grants.

We request that NIH modify its guidelines to state that its deposit requirement only applies to peer-reviewed manuscripts that report findings of empirical research and does not apply to literature reviews. NIH might consider review articles as ?low-hanging fruit? in regard to possible changes in the public access policy. It is a simple change that the scientific publishing community would appreciate.

Compensation for value added

The research published in our journals is rarely obsolete within a year; it generally has a shelf life well beyond the 12-month public access window. When copyrighted articles are freely available online, their commercial value is significantly eroded. While NIH may pay for the actual research, it is the journal publisher who bears the expense of creating the publication?from peer review to copyediting, layout, production, distribution, and archiving both digitally and in print.

When publishers are no longer able to recoup these costs through subscription revenues (i.e., from the readers), they will have to recoup them at the front end from the authors. We note that the NIH policy allows reimbursement of publication costs if they are ?actual, allowable, and reasonable to advance the objectives of the award.? We ask that NIH be more explicit about what is considered ?allowable? and ?reasonable? and make it very clear to grantees that funds may be used to cover open access fees. In addition, we would like to know how such funds will be identified in a grant and how much NIH has budgeted per year for publication costs.

Question 2: Why Doesn?t Compliance = Compliant?

AAA?s scientific research journals?The Anatomical Record and Developmental Dynamics?are now fully compliant with the NIH?s current public access policy, as mandated by Congress. Upon publication of each issue, our publisher will deposit the final peer-reviewed version of all NIH-funded articles to PubMed Central (PMC) and authorize public availability 12 months after publication. Although we object to the mandate, we are abiding by it.

However, this compliance apparently does not make us compliant enough for NIH. Only journals that make the final published version of NIH-funded articles available to PMC within 12 months will appear on the NIH list of compliant journals, the list that researchers are encouraged to check prior to submitting a manuscript for publication.

Why doesn?t actual compliance with the law entitle a journal to appear on this list? Why is NIH misleading our prospective authors by not acknowledging that we are, indeed, compliant? Isn?t it NIH that is out of compliance for seeking to go beyond the law and penalizing those who are actually fulfilling the terms of the congressional mandate?

Question 4: ?in a manner consistent with copyright law?

While we are not experts on congressional intent, we find it difficult to believe that ?in a manner consistent with copyright law? was meant to be the congressional equivalent of ?make copyright someone else?s problem.? Nonetheless, that is precisely what NIH has done. Researchers are told by NIH that the first step in complying with the public access policy is to ?Address Copyright. Before you sign a publication agreement or similar copyright transfer agreement, make sure that the agreement allows the paper to be submitted to NIH in accordance with the Public Access Policy.?

With that brief instruction, NIH appears to think that the congressional intent has been followed. Copyright protection is intended to give the copyright holder the right to determine who can adapt the work to other forms. In reality, NIH has simply redefined the term ?copyright? to suit its PMC model, forcing authors to comply because of their dependence on NIH grant support.

The copyright issues raised by implementation of this policy have been addressed in lengthy documents submitted to NIH by both commercial and non-profit publishers. We list just some of these issues here: a. PMC is reformatting and altering submitted author manuscripts. Why is this preferable to linking to the originally published document? b. NIH is exceeding its legal mandate by distributing copies of the PMC version to Web sites hosted outside the U.S., depositing manuscripts on an international mirror site with plans for additional such sites. How do these sites serve the needs of U.S. taxpayers? c. How will international copyright considerations be addressed to protect rights holders?

These issues raise important questions and concerns regarding copyright protections that would prevail both within and outside U.S. borders. By appropriating and redefining copyright in this manner, NIH has clearly gone beyond congressional intent in regard to making manuscripts publicly available and has disregarded congressional intent related to consistency with copyright law.

Question 1: NIH requested specific comments on its implementation approaches, compliance monitoring, and training offered. Assuming that the current "implementation approaches" are in fact the policies and procedures now spelled out in the PubMedCentral and NIH websites, we offer these suggestions that we believe would enhance implementation and observance of the Policy.

1. PMC now offers publishers various types of Participation Agreements, and under these publishers may submit NIH-funded articles to PMC on behalf of authors. The current file submission guidelines state: A journal must provide PubMed Central the full text of articles in an XML or SGML format that conforms to an acceptable journal article DTD (Document Type Definition). The original high-resolution, digital image files must also be provided for all figures. A PDF may be submitted in addition to the XML/SGML version of an article, but not as the primary (or only) form. and A journal that does not currently produce XML or SGML versions of its articles would have to add this process to its production stream or contract with a vendor to create XML from the article source files. Most university presses do not now operate production processes that would support production of these XML files. To suggest that they "add this process to the production stream," is not reasonable, when one considers that a press might only have a small number of NIH-funded articles to handle. We recommend that PMC alter the requirement and accept PDFs from publishers, just as PMC now does accept PDFs from authors. This would reduce the burden on many university presses and increase both required and voluntary participation.

2. The descriptive information about PMC explains that PMC is not intended to replace the original publication of the journal articles, rather to archive them and make them accessible in a particular way. The integrity of the contents then continues to rely on the editorial selection processes, peer-review processes, and to some extent on the editorial and production work provided by the journal editorial advisors and on the publishers. In order to present PMC readers with complete information about each article, we recommend that PMC incorporate the name of each journal's publisher in the primary citation of each article. Publishers should be offered the opportunity to provide a link through which readers could access the journal's and publisher's editorial policies, peer-review standards, and funding sources.

Question 4: American university presses contribute enormously to the body of research-based English-language publications offered worldwide each year. All of these member presses publish books, and 57 of the members publish 800 scholarly journals. Over 10,000 new book titles and about 12,000 journal articles are professionally selected, peer reviewed, and published through these presses each year. While many of our members' publications address the humanities and social sciences, a substantial number of our publications present information in the life and biomedical sciences. We believe that our publications are a highly efficient way for university faculty to share their peer-reviewed work both with one another and with a large general public. The NIH has requested general as well as specific comment on its Public Access Policy. We will address the broadest question first AAUP is concerned about the possible long-term indirect impact of the limitation on author publishing rights that is implicit in NIH's Public Access Policy. The Policy asserts that the funder of research has a prior claim on the publishing rights an author normally possesses under copyright law. We believe that however well-intentioned and well-executed this transfer of rights may be, it represents a major shift in rights ownership whose impact on the entire system of scientific communication is not known and cannot reliably be predicted. This transfer of rights could trigger a general shift from a "market economy" to a "subsidy economy" to organize the dissemination of articles based on NIH research. While NIH may be well prepared to step in and fund PubMedCentral at a level required to support this system, we doubt there is a likelihood of success if such a change occurs in other areas such as the humanities and social sciences. Where NIH goes others less well-funded may follow, to the detriment of their publishing institutions and infrastructure. While AAUP member presses are not at all averse to adjusting their business models, and creating new ways of doing things, AAUP suggests that unintended negative consequences to these institutions, from unplanned actions, be weighed as NIH implements its Policy. So as not to overburden this letter with information present elsewhere, we refer you to the AAUP's Statement on Open Access available at http://aaupnet.org/aboutup/issues/oa/statement.pdf

05/30/2008 at 12:24:58 PM

Connolly

Anne

Research Foundation of SUNY (RF)

Albany

NY

USA

Representative NIH Funding Recipient Organization

Question 1: The Research Foundation of State University of New York (RF) offers these thoughts as recommendations for the NIH to consider for implementation, from actions put in practice by some of the State University of New York (SUNY) campuses. 1. SUNY campuses have enhanced and supplemented the implementation recommendations of the NIH. For example, letters have been and/or will be sent to individual NIH faculty, including Chairs and Deans to make them informed and aware in the attempt to ensure compliance. These letters will be posted on individual SUNY campus websites and will also appear in campus newsletters. 2. SUNY campuses are also discussing ways to target employees (e.g., post-doctoral) on NIH grants who may also be publishing. 3. SUNY campuses have and/or soon will include statements on internal notice-of-award forms (i.e., information abstracts) that are sent to investigators identifying the need for compliance. 4. SUNY campuses have also engaged their library services to post similar information on their specific webpages. 5. SUNY campuses may maintain their own database of publications in their campus libraries, and include the library staff in the compliance process. 6. SUNY campuses have also discussed having the research administrators remind investigators to include additional publication costs (in addition to page charges and illustrations) if they are considering publishing their manuscripts in journals they know charge for submission to PubMed Central.

Question 2: The Research Foundation of State University of New York (RF) provides these thoughts as recommendations for the NIH to consider for monitoring and ensuring compliance, from actions being discussed by some of the State University of New York (SUNY) campuses. 1. SUNY campuses have discussed adding questions to their application routing forms and the yes/no questions of the COEUS system to identify if investigators have and/or plan to publish manuscripts supported by NIH grants. 2. SUNY campuses also plan to implement a review process when investigators submit their noncompetitive continuation applications to assure the publications are duly noted along with the PubMed Central numbers.

Question 3: The Research Foundation of State University of New York (RF) suggests this recommendation for the NIH to consider for additional training and/or communications, from thoughts provided by some of the State University of New York (SUNY) campuses. 1. SUNY campuses recommend that the FDP (Federal Demonstration Partnership) subaward boilerplate should include the PubMed Central language as well as all subcontract agreements.

Question 4: The Research Foundation of State University of New York (RF) includes these other comments for the NIH to consider as related to the policy. 1. The RF acknowledges and appreciates the NIH for providing the research community with time, communications, and guidance to inform investigators to help them assure compliance with the mandatory requirement. 2. The RF applauds the NIH for developing good resources (e.g., Frequently Asked Questions) further helping research administrators and investigators understand the applicability of the policy and how to meet the requirements. 3. The RF suggests the NIH needs to clarify the policy to reflect the relationship between NIH funding (as described in the FAQ) and acceptance for publication – the sole criteria described in the policy. 4. The RF appreciates that NIH has included an example of language that can be used in copyright agreements to meet the requirement. 5. The RF feels that the NIH should engage publishers and the research community in collaboration with meeting the mandatory requirement (e.g., modifying standard copyright agreements to include a provision acknowledging that the author retains the right to provide a copy of the final peer-reviewed manuscript to the NIH, and to make the article available in PubMed Central within 12 months after publication by the journal.). 6. The RF suggests that the NIH address and clarify the consequences to investigators who inadvertently fail to reserve their rights to submit to PubMed Central. 7. The RF intends to meets its responsibilities under the mandatory requirements as implemented by the NIH Public Access Policy, and we appreciate the opportunity to participate in the NIH’s request for information (RFI) by providing these observations and comments.

05/30/2008 at 12:03:02 PM

Case

Mary

MALS

University of Illinois at Chicago

Chicago

IL

USA

Representative NIH Funding Recipient Organization

Question 1: UIC supports the revised NIH Public Access Policy. We believe, however, that NIH would more effectively leverage the investment in government dollars in health sciences research by mandating an embargo of 6 months or less rather than the 12-month embargo of the current public access policy. UIC recognizes that publishers have some concern that libraries will cancel journals as a result of the NIH mandate. However, UIC will not cancel journal subscriptions due to the NIH Public Access policy, even if there were a 6 month embargo—6 or more months is too long of a delay for access to needed research while a significant number of journal articles will not be covered by the NIH Policy.

UIC is also are aware of a proposal for an alternative implementation of the Public Access Policy, where NIH would act as a dark archive and provide links to publishers' Web sites. This proposal would NOT achieve a major goal of the NIH, which is to provide a permanent, stable archive of its research. For a database to be effectively curated and for the quality of material it contains preserved, it must be used regularly. Libraries have a long history in dealing with archiving and preservation issues, and can say emphatically that a dark archive that links to publishers’ Web sites is an unacceptable alternative that NIH has consistently and wisely rejected.

Question 3: The updated FAQ's and current information on the NIH Public Access site help us to keep researchers well informed. UIC has adopted a copyright addendum, developed a NIH Policy website, and targeted mailings to NIH researchers as well as to all faculty, in a joint effort by the Provost, Office of the Vice Chancellor for Research, and the Library. Issues may arise in the next year as implementation progresses, and periodic requests for comment will allow a continuing dialog among all stakeholders.

Question 4: UIC welcomes this opportunity to express our support for the revised NIH Public Access Policy and its goal of public access to the published results of NIH-funded research.

These comments are submitted on behalf of UIC Vice Chancellor for Academic Affairs and Provost Michael Tanner, Interim Vice Chancellor for Research Larry Danziger, and Mary Case, University Librarian.

05/30/2008 at 11:15:43 AM

Joseph

Heather

MS

The Scholarly Publishing and Academic Resources Coalition

Washington

DC

USA

Other

Question 1: SPARC fully supports the NIH Public Access Policy in its current form, and commend the NIH’s extensive efforts to seek input from the full range of stakeholders throughout the policy's development. We believe the agency’s overall response to constructive input has been commendable and that a fundamentally balanced and workable policy has resulted from this process. We offer further comments in the attachment below to demonstrate the strategic soundness and overall balance of the policy, and to underscore our community’s continued willingness to work with NIH to ensure that the benefits of this policy are be fully realized by all stakeholders.

Question 2: We encourage the NIH to closely monitor key aspects of the Public Access Policy’s implementation, including: 1) Experience of publishers with six-month or shorter embargos: It is in the public's interest to reduce the duration of the public access embargo to as short a period as possible. NIH should collect data on the sustainability of biomedical journals that offer open access within six months of publication in order to evaluate the potential to reduce the maximum PubMed Central embargo. and 2) Extent to which eligible articles are captured in PubMed Central: For the policy to succeed, it is imperative that deposit of articles from NIH-funded research be nearly universal. We trust the agency will track this and take reasonable, appropriate steps to ensure success.

Question 3: Additional comments on the policy and implementation are included the full SPARC comment submission attached to this form.

Question 4: The NIH Public Access Policy embraces the potential of the Internet to enable new and increased usage of NIH-funded research findings by millions of scientists, physicians and health clinicians, public health officials, patients, small businesses, students, teachers, and others. SPARC commends NIH for its vision and leadership in putting forward this important policy.

Question 4: The University of Kansas is aware of a proposal for an alternative implementation of the Public Access Policy, where NIH would act as a dark archive and provide links to publishers' Web sites. This proposal would not achieve a major goal of the NIH, which is to provide a permanent, stable archive of its research. For a database to be effectively curated and for the quality of material it contains preserved, it must be used regularly.

Libraries have a long history in dealing with archiving and preservation issues, and can say emphatically that a dark archive that links to publishers’ Web sites is an unacceptable alternative that NIH has consistently and wisely rejected.

05/30/2008 at 09:35:29 AM

Till

Jim

PhD

University of Toronto

Toronto

ON

Canada

Other

Question 1: I hope that NIH will work toward reducing the maximum embargo period from 12 months to 6 months, which would be more in harmony with other funding agencies in Canada and the UK.

Question 1: Thieme Publishing Group, based in Stuttgart, Germany, is a privately held, medical and scientific publishing company. Thieme employs 900 people and maintains offices in 7 cities, including New York, Beijing, Delhi and Stuttgart. For 120 years, Thieme's high-quality books and journals have been a vital resource for scientists, physicians, researchers and academics. Thieme publishes 130 peer-reviewed journals and over 500 new books annually. All scientific and an increasing number of medical publications are also available online. Please visit www.thieme-connect.com for more information.

Thieme is grateful for the opportunity to respond to the National Institutes of Health (NIH) request for information regarding its Policy on Enhancing Public Access to Archived Publications Resulting from NIH Funded Research (the NIH Public Access Policy). Our written comments follow.

1) NIH should establish a formal and ongoing consultative mechanism between NIH and publishers in which NIH and publishers commit to attaining a balanced implementation of the policy that achieves the public access objectives without a negative impact on peer review publishing. The Senate committee report (110-107) to the fiscal year 2008 Labor Health and Human Services (LHHS) Appropriations bill directed NIH “…to seek and carefully take into account the advice of journal publishers on the implementation of this policy.” In addition, the Senate report highly encouraged “…collaborations with journal publishers that would enable them to deposit manuscripts on behalf of the funded investigator, if all parties agree.”

2) NIH should follow its Congressional mandate to receive a copy of final, peer-reviewed manuscripts and work with publishers to create a robust, distributed electronic network which openly and clearly displays links from unedited manuscripts in PubMed Central (PMC) which have not yet benefited from the final copyediting, fact-checking, and proofreading required for formal publication to a final authoritative version available either from the publisher’s website or, if publishers agree, from PubMed Central.

NIH should further work with publishers to enhance the MedLine/PubMed Central web site to enable full text searches of articles on the journals’ own websites. Such searches would yield links to finished articles on those websites rather than access to manuscripts as PMC now provides. Such a comprehensive search engine would do for biomedical research what search engines such as Google and Yahoo do for the web as a whole. We urge NIH to revisit this approach because it has a number of advantages to all parties.

For NIH, this arrangement would make it possible to search the text of all biomedical research articles and not just the 10% that are based on NIH-funded research. Journals, and especially high-quality journals that publish a significant proportion of NIH-funded research, would still be able to determine their own access policies within a 12-month window and based upon their own cost recovery requirements. Finally, and perhaps most importantly, instead of access to manuscripts, this would make it possible to locate the final copy-edited articles of record presented in context with links to related materials such as commentaries and corrections.

In working with publishers to pursue this alternate implementation of its Public Access Policy, NIH should consider the example of the America Competes Act (ACA) of 2007 which shows how the goal of public access to government funded research can be solved in a way which does not endanger the intellectual property rights of private industry, its support for peer review, and the integrity of the scientific record. Section 7010 of the ACA states: The Director (of the National Science Foundation) shall ensure that all final project reports and citations of published research documents resulting from research funded, in whole or in part, by the Foundation, are made available to the public in a timely manner and in electronic form through the Foundation’s Web site.

Question 2: NIH should establish a formal and ongoing consultative mechanism between NIH and publishers in which NIH and publishers commit to the following specific compliance goals:

1)Ensure that individuals post the correct manuscript version to PMC to be publicly available at the correct time, consistent with publisher agreements 2)For publishers who submit manuscripts directly into PubMed Central, ensure that articles will not be accepted from individuals or entities other than the publisher 3)Create and disseminate to publishers detailed and robust PMC bibliographic usage statistics to monitor and identify piracy and other inappropriate usage of manuscripts and other copyrighted material posted on PubMed Central 4)Identify and implement specific safeguards to prevent copyrighted material available on PMC from being altered, pirated, made into derivative works, redisplayed, republished, resold or used for any other commercial purpose 5)Establish specific procedures, including notification of publishers, that will be implemented if piracy is discovered as a result of downloading content from PubMed Central 6)Ensure that the Policy is, and continues to be implemented in a manner consistent with copyright law

Question 3: The Professional and Scholarly Publishing Division of the Association of American Publishers and the DC Principles Coalition have prepared and submitted a thorough list of the information and communications related to the NIH Public Access Policy that would be helpful to publishers. Thieme agrees that these questions should be fully and publicly addressed by NIH.

The information and communications requested are as follows:

1) Regarding Consultation with Publishers, Societies and Authors

•Many investigators are not aware of the new policy. Does NIH have a formal mechanism and the necessary resources to handle the questions that will arise from authors and journals? •What is NIH’s timeline for amending this policy moving forward? •What mechanism will NIH put in place to continue the dialogue with publishers that will help ensure this policy is “implemented and steered” effectively and that publisher concerns are addressed?

2) Regarding Copyright •Why hasn’t the NIH supported the full value of copyright and its use in business models including those which involve driving traffic to a publisher site, and permit linking to publishers’ web sites, rather than requiring deposit at PubMed Central?

3) Regarding Brand Protection, Repurposing and Piracy •What mechanisms will NIH put in place to ensure that any revisions to copyrighted materials such as reformatting, enhancing, linking or otherwise changing the articles respect the integrity of the copyrighted content it receives? What assurance will NIH give that this will be done in accordance with guidelines agreed to with publishers? •Will NIH identify precisely how manuscripts will be linked to databases and other resources, and which databases? Publisher concerns about links include: a) would links within the article obscure the information in the text? b) Would it change the editorial emphasis by seeming to suggest that certain information within the article is more important than other information, simply because there is a link? c) Would it be appropriate to change that emphasis in the context of the research and the article’s focus? •How will NIH ensure proper protection of publisher or society trademarks and branding? There been no affirmation of these markers of quality, and often branding information is missing, potentially misleading users to the erroneous conclusion that the NIH is claiming copyright, or that the content is in the public domain. •How will NIH respect the rights of copyright holders and stipulate what NIH will or will not allow related to third-party use of its works? Will NIH, for example, ensure that manuscripts are not distributed to other sites around the world besides PubMed Central? Will NIH implement guidelines that explicitly prohibit third parties from exploiting content that appears on PMC without the consent of the publisher? •How will NIH prevent piracy of the articles from PubMed Central? Will NIH prevent copyrighted material available on PMC from being altered, pirated, made into derivative works, redisplayed, republished, resold or used for any other commercial purpose? What will happen if piracy is discovered as a result of downloading of content from PubMed Central and will NIH notify publishers? •If deposited content will be “mirrored” to other sites outside the U.S., after publisher approval, how will the sites be established, and how would national and international copyright considerations protect rights holders? What guidelines will NIH agree to with publishers before any distribution of copyrighted content occurs on PMC international mirror sites?

4) Regarding Compensation •What latitude will NIH have in negotiating terms and conditions directly with publishers and other rightsholders who might wish to undertake direct licensing arrangements with NIH that would enable the deposit of copyrighted works on behalf of authors? Given that NIH’s policy would amend many journal copyright policies and effectively reduce the value of those rights, will NIH be empowered to negotiate such licensing terms, including publication charges/payment, as certain non-government funding agencies have done? •The policy provides for publisher deposit of final peer-reviewed manuscripts on behalf of authors, and includes allowance for grantees to use grant funds in the payment of publication fees. How will such funds be identified in the grant and what has NIH budgeted per year for such costs over the next five years?

5) Regarding Scope •If other public or private funders support research also supported by NIH, what will researchers be expected to do if these other sources oppose the posting of their funded work on PubMed Central? •Will NIH agree to stipulate that its requirement for the deposit of peer-reviewed manuscripts in PubMed Central only applies when NIH funding represents substantial funding for the research on which the scholarly work is based? •The policy also holds that “Principal investigators and their institutions are responsible for ensuring all terms and conditions of awards are met.” Yet, this includes the submission of articles that arise directly from the investigators’ NIH-funded research even if they did not author or co-author the publication. In fact, NIH-funded investigators and institutions are being held responsible for making sure these other authors are “aware of and comply with” the NIH policy. How could they comply with this provision? •What will the repercussions be for investigators and journals that do not follow the process? •NIH’s 2005 voluntary policy stated that it did “not apply to contributed book chapters, editorials, reviews, or conference proceedings.” Rather, it applied “only to peer-reviewed research publications.” Will NIH modify its guidelines to state that its deposit requirement only applies to peer-reviewed manuscripts that report findings of empirical research and does not apply to literature reviews?

6) Regarding Integrity of Research, Quality Control and Meaningful Public Access •How will the NIH know the final month of publication when the month is not always established upon acceptance to a journal? •Many manuscripts currently appear on PMC in violation of publisher policies. How will NIH ensure under the new public access policy that individuals post the correct manuscript version to PMC to be publicly available at the correct time, consistent with publisher agreements? Will NIH ensure that embargo and posting policies are implemented on a journal-by-journal level or at least publisher-level? Will NIH provide a detailed description of the process at NIH to monitor and ensure prompt take-down of manuscripts improperly submitted? •For publishers submitting directly, how will NIH ensure that manuscripts will not be accepted from individuals or entities other than the publisher? •How will NIH ensure that researchers are not misled as to the accuracy and validity of manuscripts on PMC? Will there be pointers to final published versions on publisher sites? Will NIH to develop, for example, a special section within PMC for members of general public/patients to “land” on suitable information for patients and “disclaimers” that the PMC author manuscript represents only a small part of the literature, with references and links to voluntary health organizations (VHOs), Patient Inform, publisher sites? •How will NIH deal with plagiarism and ethics issues? Will NIH establish guidelines in consultation with publishers on how to deal with corrective notices, corrigendum, and retractions?

7) Regarding Cost •NIH faces funding shortages from the federal government. How much will it cost to effectively implement this policy? •Does this cost detract from funds to grantees actually conducting the innovative research that advances science?

8) Regarding Measuring Impact and Effectiveness •Will NIH provide publishers with detailed and robust PMC bibliographic usage statistics that will enable them to assess the impact of PMC usage on their subscriptions? •What oversight or governance will monitor whether NIH’s performance in pursuit of its intended purpose a) is met; b) is not costly for the taxpayer; c) is not burdensome on research investigators; or d) does not have a negative impact on the integrity of the scientific and medical literature (e.g. errors and versioning problems introduced, economic harm to journals and publishers)? •What steps will NIH take if it is found that its Public Access Policy is hurting rather than advancing scientific research?

Question 4: Thieme appreciates the NIH’s vision for an interconnected world of science and support efforts to enhance public access to scientific research. The STM publishers’ investments have made more information available to more people in more ways than at any time in human history and the STM publishers’ continue to innovate. Like other publishers, the STM publishers’ are experimenting with data mining and visualisation tools, semantic web applications, online navigation aids, flexible displays, free access to the recent archive of published articles, and Web 2.0 applications. The STM publishers’ are also actively supporting the development of international standards to enhance online publications and websites and maximise the discoverability of science.

This investment of resources has created and continues to fuel a system of scholarly communication which is vital to the advancement of science and the determination of critically important personal and professional rewards for scientists throughout the world. While Thieme appreciates NIH’s pledge to work constructively with publishers to fully address copyright concerns and make the policy work, Thieme is troubled by NIH’s lack of concern for any dislocation that will result from adhering to NIH’s “implement and steer” approach for the major shift in policy from voluntary to mandatory submission. Improper implementation of this sweeping mandate has serious implications for all stakeholders in the research community (publishers, authors, and the public) and for science itself. It is important that these implications be fully considered and addressed as soon as possible and Thieme welcomes the opportunity to work with NIH to establish the kind of productive ongoing dialog that we feel will best serve the public interest.

05/29/2008 at 10:34:08 PM

Dobbs

Aaron

MSLS, MSM

Shippensburg Univeristy of Pennsylvania

Shippensburg

PA

USA

Other Member of the Public

Question 1: There is a pattern emerging among responses to the NIH call for comments that indicates opponents are pressing for PubMed Central to be made into a dark archive that links to publishers’ Web sites. This does NOT meet the goals of public access and is NOT an acceptable approach to the policy.

Consider automatic notification to be sent to the campus office of research when an article from that institution has been deposited into PubMed Central

Consider automatic means of coordinating manuscript deposit between PMC and institutional repositories, possibly in batch uploads or downloads. (Indicate if you or your institution would be willing to help facilitate).

All future grant NIH applications should include a field requiring citation to all previously required PubMed Central deposits; failure to cite would be considered reason to return the application as incomplete

Question 3: A published list of publishers whose author publishing agreements provide for deposit with PMC in a manner that is consistent with copyright law would help steer research to publications with compatible aims.

Question 4: Could the embargo period be shortened to 6 months? This would reflect the pace of biomedical research and discovery, align NIH policy with others in place worldwide, and keeps US research institutions competitive with rest of world.

05/29/2008 at 06:54:21 PM

Ogburn

Joyce

MSLS, MA

University of Utah, University Librarian

Salt Lake City

UT

USA

Representative NIH Funding Recipient Organization

Question 1: The University of Utah fully supports the NIH Public Access Policy and looks forward to the enormous benefits that will result from its implementation. Researchers, patients and others would benefit from changing the requirement for deposit from 12 months to 6 months. This would not harm the market for journals while it places information in the hands of medical practitioners and researchers much sooner. Many rural communities, health care workers, American Indian communities, and others that lack access to a big research institution and availability to research results need this information without ado. Our libraries will continue to subscribe to journals for our researchers and practitioners who need access upon publication.

Alternate access means have been proposed to have the NIH point or link to articles at the publishers’ sites. This approach is not true public access since the articles would not be in a public space and there are no guarantees that this method would be permanent or stable. It does not meet the goals of preservation and curation. This approach also does not lend itself to data mining by the NIH, which may seek to understand trends or the impact of NIH funding programs. The content and the control of access and use still remains in the hands of the publishers, not the NIH.

Question 2: Developing an automated system for alerting institutions when an article has been submitted would be a terrific way to allow institutions to track the submission. Additionally we would like to harvest or be sent the metadata to place in our repository to link to research generated at our institution. We would then have an institution specific, searchable record of compliance and success in publishing research results. The Marriott Library has developed software to enable easy deposit of articles and we would be interested in working with the NIH on envisioning an alert system that works with repositories.

Question 3: The University of Utah supports the public access policy and has commented before. We have committed fully to compliance and want to hear that the policy is in full implementation mode and achieving its goals. Keeping information and FAQs current will be helpful in answering our researchers’ questions. We would also appreciate information about how publishers, libraries or others are lending their support by providing deposit services or tools.

Question 4: The University of Utah believes that this policy supports our mission and presents a tremendous opportunity to transform access, use and generation of research, the processes of discovery and innovation, and patient care. We thank the NIH for the opportunity to reiterate our support.

05/29/2008 at 06:29:12 PM

Watson

Linda

MLS

Association of Academic Health Sciences Libraries

Seattle

WA

USA

Representative NIH Funding Recipient Organization

Question 1: I submit these comments on behalf of the Association of Academic Health Sciences Libraries (AAHSL), an organization of library directors of the 142 accredited and American and Canadian medical schools that belong to the Association of American Medical Colleges. AAHSL expresses its deep appreciation for the efforts that NIH is taking to ensure an effective implementation of the updated Public Access Policy (NOT-OD-08-033) and its continued willingness to engage all stakeholders in this process. We are optimistic that this policy will speed the pace of discovery by expanding access to research findings supported with federal tax dollars in order to better advance science and improve health. AAHSL is a strong supporter of the NIH Public Access Policy.

Our member libraries lend strong support to their institutions’ efforts to comply with the policy. We have been recognized as leaders on our campuses in addressing policy issues related to author’s rights. We have worked to educate our faculty about the need to retain rights when signing publication agreements with publishers. We have encouraged our faculty to retain rights to use their work in teaching, for posting on their personal websites, or depositing to our institutional or subject repositories. This new public access policy that affects so many of our researchers directs increased attention to the issue of author rights, an issue of high importance to the advancement of scholarship.

During the Medical Library Association Annual Meeting in May an overflow audience attended a session on the public access policy with participation from staff at NLM. It is clear there are many unanswered questions for both libraries and authors. Of particular concern are issues around deposit requirements, copyright and version control. For the latter, there are questions about which copy authors cite and how to address significant editorial changes after the author’s final manuscript is submitted.

To date our member libraries have limited experience upon which to base comments regarding the policy and its implementation. To assist authors our members have developed outstanding training materials and guides that supplement the material supplied by NIH. Additionally, the policy has offered a valuable opportunity for members to collaborate across the campus involving libraries, faculty and research offices.

We urge that NIH work with publishers and institutions to develop a consistent and streamlined procedure for deposit that addresses rights questions and other implementation issues, and which can be used by all NIH-funded PIs without reference to the specific policies and practices of individual journals and publishers. AAHSL would be glad to work with NIH and interested peer institutions to develop and implement this procedure. We also suggest NIH develop a means to coordinate manuscript deposit between PMC and institutional repositories.

Question 2: The process for monitoring is a concern for many of our members. We suggest that NIH consider providing routine communications to research offices on compliance issues.

Question 3: We urge NIH to continue its work to streamline the deposit process and the timely updating of its website along with announcements of the updates.

Question 4: We thank NIH for its efforts to ensure a smooth implementation of the Public Access Policy. We believe the policy will result in a significant improvement in access to health information for our faculty, students and the academic medical centers that we serve.

Question 1: Creating a parallel system for copy editing, proof-reading by authors, and archiving is a waste of taxpayers' money and authors' time. These processes are already carried out by authors and publishers in the course of publishing journal articles. If publishers agree to make publications resulting from NIH-funded research freely available within 12 months of publication, this will achieve the same goals as those specified in the NIH mandate, at a much lower cost to NIH. Allowing complete public access to such archives could be arranged and I'm sure would be preferable to publishers than the proposed policy. If publishers did not agree to these stipulations, then authors could be required to deposit articles on the PMC site. Furthermore, creating a dual manuscript preparation and archiving system will inevitably result in discrepancies between two available versions, leading to confusion over which one is considered the "official" version. It is also not clear why NIH is not including a link in PMC to the original publication website.

Question 3: Clarification regarding the applicability of the mandate to researchers with partial support from NIH is needed. For example, is the mandate intended to apply to any research carried out with NIH support, regardless of how small that portion was, or to new studies that make use of data originally collected with NIH support? What if other funding agencies involved in support of the research have alternative policies regarding public deposition of papers?

Question 4: Publishers and small scientific societies rely on subscription revenue to support their operations. Reduction of paid subscriptions could negatively impact the ability of editorial offices to function, and by extension, the quality of scientific papers.

05/29/2008 at 05:24:46 PM

Soules

Aline

MA, MSLS, MFA

California State University, East Bay

Hayward

CA

USA

Representative NIH Funding Recipient Organization

Question 1: This is an addendum to comments I posted on May 27:

It has come to my attention that there is a proposal that the NIH policy be implemented through a dark archive that links to publishers' web sites. This is not an appropriate alternative. The requirement is for “public” access. There's nothing public about directing the public to sites where it has to pay for information that has already been paid for through public funds. An important goal is to make public the information discovered or created through NIH-funded endeavors.

Another major goal is to provide a permanent, stable archive. This requires that the material be centralized (not scattered among publishers' web sites and in various forms). A central repository ensures that the information will be curated, preserved, and used on a regular basis. As a librarian, I can assure you that a dark archive does not achieve appropriate archiving and preservation needs. NIH has consistently and sensibly rejected this alternative in the past and I urge NIH to continue to reject this idea in favor of promoting the public dissemination of information through the access of PubMed Central.

05/29/2008 at 05:04:56 PM

Lougee

Wendy

MA, MLS

University of Minnesota Libraries

Minneapolis

MN

USA

Representative NIH Funding Recipient Organization

Question 1: The University of Minnesota Libraries support the efforts that NIH is taking to ensure an effective implementation of the updated Public Access Policy. We believe that this policy will speed the pace of discovery by expanding access to research findings supported with federal tax dollars in order to better advance science and improve health.

The NIH public access policy directs welcomed attention to the issue of author rights. Our University encourages faculty and students to exercise their interests in ownership and use of their copyrighted works in a manner that provides the greatest possible scholarly and public access to their work. We have worked over the past year on a number of initiatives to support this goal including conducting an educational campaign on author rights (http://www.lib.umn.edu/scholcom/au-rights.phtml) and the creation of an institutional repository (http://conservancy.umn.edu/). The University of Minnesota, as a member of the Committee on Institutional Cooperation (Big 10 schools plus Chicago) has endorsed an “addendum to publication agreements” for authors to use with their publishers to retain rights for use of their work in their teaching, for posting on their personal websites, or depositing to institutional or subject repositories, such as PubMed Central.

University Libraries have invested significant resources ensuring that our staff are informed about the policy and are prepared to assist authors with the submission process. We have developed a successful partnership with the Office of the Vice President for Research to implement the policy. We have created a website to centralize all information and institutional advisories about the policy (http://www.lib.umn.edu/scholcom/NIHaccess.phtml); met with faculty and administrative committees to discuss the policy and plan its implementation; provided notice to Principal Investigators about their responsibilities; and created a letter to publishers from the Vice President for Research for use by authors in the first submission of a manuscript that informs publishers of University of Minnesota intent to comply with the NIH policy and requests their support in permitting deposit of manuscripts. Finally, we have shared best practice experiences with colleagues at other institutions.

We encourage NIH to work toward reducing the maximum embargo period from 12 months to 6 months, which would be more in sync with other funding agencies in the UK and Canada, and the Howard Hughes Medical Institute. A 6 month embargo maximum would also be consistent with the CIC addendum mentioned above, creating less confusion for our authors.

A 6 month embargo provides a sufficient safeguard for publishers. The faculty and students at the University of Minnesota require the most current information for their research and study – a delay of 6 months for access to critical information is not acceptable. The journals to which we subscribe are based on faculty needs, quality and use of the journals in our setting, and our budget situation which changes from year to year. The NIH Public Access Policy is NOT a factor in our cancellation decisions. However, it COULD be a factor in our assessment of journals to subscribe to in the future – favoring those journals which comply with the NIH Policy and are supportive of our authors in facilitating that compliance.

Question 2: We urge the NIH to work with all stakeholders to reduce the administrative burden of compliance on institutions and authors, and to streamline the process wherever possible. One example would be for NIH to generate a message to the institution upon the deposit of a manuscript for their respective authors. Ideally, over time, our authors will have ensured the right to deposit these manuscripts in institutional repositories as well as PubMed Central. When that is the case, we would like to see an efficient mechanism for the PubMedCentral manuscript to also be deposited in our own IR.

The submission process would be facilitated by the availability of a comprehensive, up-to-date location for recording individual publisher policies. NIH could work with SHERPA and others to create and maintain this and integrate it with the submission system. NIH should work to influence additional publishers to participate as “fully compliant” partners.

In addition, NIH should ensure that all NIH grant application forms or electronic submission sites include a prompt or a field for inclusion of the PMCID on the PI’s cited references that fall within the policy.

PubMed Central should develop the functionality to identify how many times a particular article has been accessed in order to add to the growing evidence of increased use of publicly accessible research.

Question 3: We encourage the NIH to continue to update the Public Access website, and provide as much detail as possible in the FAQs. We rely on this information to inform our authors of new developments or clarifications. NIH should consider an RSS feed on the appropriate pages so that we can be alerted to updates.

NIH could clarify in the FAQs that authors need not pay OA fees to publishers to comply with the NIH mandate.

Question 4: We appreciate NIH efforts to ensure a smooth implementation of the Public Access Policy. We believe the policy will result in a significant improvement in access to health information that will benefit both our university and the publics it serves. This result would not be achieved if suggestions of a "dark archive" were pursued. We encourage NIH to reject that approach and continue to focus on the development of PubMed Central as a permanent stable archive.

05/29/2008 at 04:53:38 PM

Graves

Diane

MLn

Trinity University, San Antonio, TX

San Antonio

TX

USA

Representative NIH Funding Recipient Organization

Question 2: RE: the proposal of an alternative implementation of the Public Access Policy, with NIH acting as a dark archive, providing links to publishers' web sites. In effect, this would limit public access and thereby defeat the intent of the program. From a library perspective, I don't see this as an effective, feasible, or reliable alternative. Public access to a collection of publicly funded research is what is needed, not a dark archive. In many cases, PORTICO is answering that need, which addresses long-term preservation, not public access.

05/29/2008 at 04:49:01 PM

Smith

Kevin

J.D.

Duke University

Durham

NC

USA

Representative NIH Funding Recipient Organization

Question 1: In general Duke researchers have been pleased with the simplicity of the interface provided by PubMed Central for submission of articles. The most difficult and time consuming issue in terms of compliance has been the education needed to help faculty deal with copyright issues and the wide variety of publication agreements with which they are confronted. Although this is a significant opportunity to help faculty adopt more appropriate copyright management strategies in general, much of the stress for researchers could be eliminated if the NIH would take two steps: 1. Solicit and complete participation agreements with as many publishers as possible, including those who publish the “top-name” journals in fields covered by NIH research funding. 2. Maintain communication with those publishers who decline to enter into participation agreements to negotiate the smoothest possible terms of submission. Agreements and policies that are not full participation agreements but that facilitate submission should be communicate on the NIH website, just as the list of participating publishers is now.

Because we believe that there is both an advantage to our researchers and to the general public in having a stable and permanent archive of taxpayer-funded research, we must view the suggestion sometimes heard for a “dark archive” of articles with links to publisher websites as an unacceptable alternative. This suggestion would not achieve the goals articulated by the NIH, nor would it provide the benefits which are the reason for the support of so many institutions of higher education and research. This alternative was wisely rejected by NIH in its initial consideration and should not be reconsidered at this time. Our institution, like many others, has already invested substantial resources in compliance with the policy as now written, and a substantial change, particularly one that would undermine the benefits we see in the policy, would be a serious problem.

Question 2: Duke has already adopted policies and taken significant steps toward educating our faculty researchers about managing copyright and submitting articles, as detailed in our earlier submission of comments. The information we provide for researchers can be seen at http://www.mclibrary.duke.edu/nihpolicy. The most helpful thing that NIH can do to help us monitor and ensure compliance with the public access policy is to adopt a clear policy and stick with it without significant alteration. A consistent and stable policy will allow institutions to develop their own mechanisms for compliance. Institutions can also use the NIH policy as a part of overall efforts to managing the intellectual property assets created at a university in a more efficient and beneficial way.

Question 3: Two specific steps that NIH could take would help to facilitate communication and make compliance with the public access policy smoother and more efficient. First, it would be best to send the final PMC version of an article for verification before it is uploaded to the database to BOTH the principle investigator and the lead author listed on the article. This would help PIs remain aware of work being done, especially on widely diffuse research projects, and it would reduce the bottleneck of articles that are pending PMC availability because a PI fails to complete this final step; lead authors, when different from the PI, will have a much greater incentive to complete this verification. Second, it would be tremendously helpful to institutional monitoring efforts, and beneficial to the smooth implementation of the policy, if notification could be sent to the designated institutional research office if, after a designated period of time, there had been no response to a request for verification of a final article text for PMC. Grantee institutions have a significant stake in compliance, and notice of this impediment is important if the research support offices are to be of material assistance in overseeing compliance.

Question 4: General comments regarding the overall policy of Duke University regarding the NIH public access policy have been submitted by Deborah Jakubs, University Librarian & Vice Provost for Library Affairs, and Pat Thibodeau, Duke Medicine Associate Dean for Library Services.

Question 1: The American Psychological Association (APA) is the largest scientific and professional organization representing psychology in the United States and the world's largest association of psychologists with 148,000 researchers, educators, clinicians, consultants, and students. APA is also the largest publisher of behavioral science research, with 37 of the premier scholarly journals in the field of psychology. Given that behavioral factors contribute to six of the leading causes of death in the U.S., it is clear that psychological science has a critical role to play in improving the health status of our nation.

Accordingly, APA strongly supports efforts to enhance public access to scientific publications that advance science and benefit the public, while safeguarding the copyright interests of publishers. Our overriding concern with the new mandatory NIH public access policy is that it uses public taxpayer funds to duplicate services that are currently provided by publishers. Moreover, when peer-reviewed manuscripts are made widely and freely available on line, the commercial value of the finished, published work is likely to be seriously diminished, with resulting declines in subscriptions and licensing agreements. This loss of income, which will be particularly acute for non-profit scientific society publishers like APA, is likely to lead to less science publishing, and thereby, less public access to research findings. A compelling alternative way to accomplish the goals of the NIH policy would be for publishers to provide NIH with immediate access to journal articles for internal portfolio management and archiving of publications arising from NIH-funded research and for NIH to provide public access to the final published articles through existing PubMed Central (PMC) links to journal Web sites.

In response to the NIH Request for Information, we would like to raise a number of specific concerns about the NIH procedures currently in effect to implement the new mandatory public access policy and suggest ways that they might be addressed:

a) Preserving Copyright Interests

It is essential to realize that publishers add immense value to the scientific enterprise through such functions as editorial selection, peer review, copyediting, and design production. Underlying the new public access policy is the faulty presumption that publishers will not experience significant financial hardship due to the 12-month lag between date of publication and posting of the peer-reviewed manuscript in PMC. While this may be true for a handful of publishers, it hardly applies to the industry as a whole, and certainly not to our association. This is due to the fact that the cutting-edge research that APA publishes is rarely obsolete within a year, and may have a shelf life of five to ten years. Moreover, only 15 percent of the eventual “lifetime” usage of our journal articles -- in the form of downloads -- occurs within the first year after publication. In clear violation of copyright principles, the NIH public access policy requires publishers for the first time ever to essentially forego their copyright interests without just compensation for their investments.

As a means to address this concern, the NIH policy does allow for the use of grant funds for the payment of publication fees for NIH-funded authors provided that certain stipulated conditions are met. This approach could work provided that NIH grant reviewers approve publication costs included in biomedical, behavioral, and social science research grants. Alternatively, NIH could set aside funds to enter into direct licensing arrangements with publishers to deposit copyrighted work on behalf of authors as some other non-governmental funding agencies have done, such as the Wellcome Trust and the Howard Hughes Medical Institute.

b) Maintaining Quality of Scientific Publishing

The public access policy by its very nature compromises the quality of scientific publishing by ultimately making available two versions of scientific papers. The first is the inferior, peer-reviewed manuscript that has not yet benefited from the final copyediting, fact-checking, and proofreading required for formal publication, and the second is the definitive, publisher-authenticated version.

To distinguish between these two versions and increase accessibility to the published version, the following changes should be made to PMC to: 1) ensure that the NIHPA author manuscript bar or some other watermark appears on the printed version of manuscripts as it does on the on-line and PDF versions; 2) make the “Author Manuscript” label larger and more obvious on abstract and html pages; 3) make the link to the published version at least as large as to the manuscript version on the abstract landing page; 4) change the title of the link to the published version, e.g., from “APA Full Text” to “APA Published Version;” 5) ensure that the links to the journal citation on the publisher sites are functional; and 6) ensure that the html and publisher sites are fully branded. c) Narrowing Scope of Policy Coverage

The relevant statutory provision in the Consolidated Appropriations Act applies to “all investigators funded by the NIH,” yet does not specify whether the NIH funding is in whole or in part. NIH takes the view that the policy applies to investigators with any NIH intramural research funds or any amount of direct costs funded by NIH, even if the funding is insignificant and supplemented by other public or private sources. But what if these other sources oppose the posting of their funded work on PMC? To address these concerns, NIH should stipulate that its requirement for the deposit of peer-reviewed manuscripts in PMC only applies when NIH funding represents the majority of funding for the scholarly work.

It is also of concern that NIH has expanded its claimed domain of manuscripts required for PMC deposit from reports of NIH grant-supported empirical research to include literature reviews. This is a significant expansion without a statutory basis. Literature reviews can arise from various contexts, which may or may not be directly related to a funded NIH grant. It is essential to clarify which review articles must be deposited. Accordingly, the language in the FAQ should be modified to explain that only those review articles that are anticipated by, and described in, an NIH-funded grant proposal are subject to the PMC deposit requirement. The guidelines should be further modified to stipulate that the policy does not apply to any grants issued before its effective date of April 7, 2008. The guidelines currently apply to NIH grants or cooperative agreements “active” in FY 2008 (which began on October 1, 2007). This sets in place an unfair, retroactive imposition of grant terms and conditions that could extend back for years prior to the official implementation date.

Question 2: NIH would be well advised to reconsider the burden that it is placing on investigators and institutions and to implement procedures and protections to secure the copyright interests of publishers. These specific concerns are addressed more fully below:

a) Undue Burden on Authors and Institutions

According to the relevant statutory provision, it is the responsibility of NIH, not the institutions or investigators as NIH contends, to “implement the public access policy in a manner consistent with copyright law.” Yet the policy states that “Principal investigators and their institutions are responsible for ensuring all terms and conditions of awards are met.” This even includes the submission of manuscripts that arise directly from the investigators’ NIH-funded research even if they did not author or co-author the publication. In fact, NIH-funded investigators and institutions are being held responsible for making sure that these other authors are “aware of and comply with” the NIH policy. This provision should be removed, because authors cannot reasonably be expected to comply with it.

b) Needed Procedural Changes

As a means to help protect the copyright interests of publishers, the following procedural issues need to be addressed. First, highly visible links need to be put in place in PMC to publishers’ copyright and disclaimer documents, not just to those developed by NIH. Second, any NIH revisions to the publisher-submitted, peer-reviewed manuscript need to be approved by the publisher, as well by as the author, prior to PMC posting, including links to databases and other resources. And third, when there is a publisher agreement in force, the author should not be able to designate an embargo date in PMC and thereby potentially alter an embargo date already agreed upon with the publisher; rather NIH should defer to the embargo policy of that particular publisher.

c) Needed Protections

Also, there needs to be a process in place to determine and monitor whether peer-reviewed manuscripts are and will be appropriately posted in PMC, and if improperly placed by authors, that manuscripts are promptly removed from PMC. In this regard, APA has identified close to 100 peer-reviewed manuscripts of articles published in our journals that have been improperly placed by authors in PMC in violation of copyright (prior to the implementation of the mandatory policy). Furthermore, protections need to be put in place to ensure that third parties cannot exploit PMC-posted content for commercial purposes and that publisher and society trademarks and branding are safeguarded.

Question 3: Although the various PowerPoint training materials posted on NIH’s Public Access Communications and Training Web site are helpful in explaining the public access policy and its overall implementation with respect to authors and institutions, there needs to be more attention directed to publishers. The general message is clear, “authors of articles arising from NIH funds are responsible for ensuring that publishing agreements allow for full compliance with the policy.” However, guidance such as that provided in the January 2008 NIH Extramural Nexus article entitled, “What the new public access requirement means to the NIH-supported investigator” can be seen as undermining the role of many publishers by posing the following questions:

"Does your institution wish to designate an individual or department to help investigators submit their own manuscripts?"

In addition to this one Web site and the explanatory page linked from the citation sites, it would be helpful to have some guidance on the actual pages that provide links to the peer-reviewed manuscripts and final published journal articles to help inform both the scientific community and the lay public about the difference between the two and how the latter can be obtained from the publishers.

Furthermore, NIH’s instructions to authors about the PMC manuscript deposit process should include language directing authors, when preparing their grant proposals, to check on the deposit fees and charges required by the journal(s) to which they intend to submit their work for publication. NIH also needs to change the wording of its FAQ about publication costs to clarify that publication fees, page charges, and NIH deposit fees are authorized for payment with NIH grant funds.

Question 4: To date, NIH has engaged in a highly unconventional process of signaling its intent to put a new policy into effect with little advance notice and then soliciting public comment within three weeks of its expected implementation date, with the prospect of announcing possible amendments to the policy six months later. Apparently, NIH considers the transformation of its current voluntary public access policy into a mandatory one as merely an interpretation of an existing policy that requires only the posting of a “revised” policy rather than a formal Notice and Comment Rulemaking.

However, this reflects a woeful miscalculation of the potential impact of this policy on our economy and international trade. Journals published by U.S. scientific, technical, and medical (STM) publishers represent about $3 billion in annual revenue, and North America-based STM publishers account for 45% of all peer-reviewed research papers published annually worldwide. The mandatory NIH public access policy would provide free, world-wide access to U.S. scientific research to countries that are competing with American business and industry, undermining the intent of the America Competes Act.

Therefore, NIH would be well advised to carefully consider the input that it receives from publishers and other key stakeholders and amend the policy to effectively address their compelling concerns. Such a deliberative approach would be in keeping with the guidance provided by the U.S. Senate in report language that accompanied the omnibus appropriations bill. Specifically, the Senate requested that NIH “seek the advice of journal publishers on the implementation of the mandate to ensure that publishers’ copyright protections are maintained.” The scientific publishing community is dedicated to the widespread dissemination of scientific research and welcomes the opportunity to work closely with NIH to ensure that the goals of the public access policy are achieved and that the scientific publishing industry is preserved in the process.

05/29/2008 at 03:46:52 PM

Michalak

Sarah

MLS

University of North Carolina at Chapel Hill

Chapel Hill

NC

USA

Representative NIH Funding Recipient Organization

Question 1: Along with many institutions many institutions, we work to educate faculty about their copyrights and related responsibilities; clear guidance and greater assistance from NIH to researchers would be beneficial.

Question 2: UNC-Chapel Hill has signaled our commitment to open access and to the NIH open access policy by providing institutional education, training, and financial support (http://www.hsl.unc.edu/scholcom/OAFundAnnounce.cfm) to facilitate compliance by our researchers. It would be a benefit to our office and our efforts to receive automatic notification whenever an article has been deposited by a UNC researcher.

UNC is also developing an institutional repository and would welcome a means to coordinate manuscript deposit between PubMed Central and the repository. We would eagerly participate in, facilitate, test, or otherwise help to advance such an arrangement.

Question 4: This submission supplements our earlier comments and reiterates our support for this policy. We applaud the commitment NIH has shown in pursuing this policy and engaging with all stakeholders. We also wish to express the commitment of UNC’s libraries to maintaining journal subscriptions. Journals continue to play a unique role in the scholarly communications process and we have no intention of canceling subscriptions as a result of the NIH Public Access Policy.

We take the position that open access to federally funded research is not simply an educational or economic issue, but also a moral one that will place vital information into the hands of the very public whose taxes support the advance of science.

--Sarah C. Michalak, University Librarian and Associate Provost for Libraries, on behalf also of Tony Waldrop, Vice Chancellor for Research and Economic Development, and Carol Jenkins, Director of the Health Sciences Library

05/29/2008 at 03:46:16 PM

Michalak

Sarah

MLS

University of North Carolina at Chapel Hill

Chapel Hill

NC

USA

Representative NIH Funding Recipient Organization

Question 1: Along with many institutions many institutions, we work to educate faculty about their copyrights and related responsibilities; clear guidance and greater assistance from NIH to researchers would be beneficial.

Question 2: UNC-Chapel Hill has signaled our commitment to open access and to the NIH open access policy by providing institutional education, training, and financial support (http://www.hsl.unc.edu/scholcom/OAFundAnnounce.cfm) to facilitate compliance by our researchers. It would be a benefit to our office and our efforts to receive automatic notification whenever an article has been deposited by a UNC researcher.

UNC is also developing an institutional repository and would welcome a means to coordinate manuscript deposit between PubMed Central and the repository. We would eagerly participate in, facilitate, test, or otherwise help to advance such an arrangement.

Question 4: This submission supplements our earlier comments and reiterates our support for this policy. We applaud the commitment NIH has shown in pursuing this policy and engaging with all stakeholders. We also wish to express the commitment of UNC’s libraries to maintaining journal subscriptions. Journals continue to play a unique role in the scholarly communications process and we have no intention of canceling subscriptions as a result of the NIH Public Access Policy.

We take the position that open access to federally funded research is not simply an educational or economic issue, but also a moral one that will place vital information into the hands of the very public whose taxes support the advance of science.

--Sarah C. Michalak, University Librarian and Associate Provost for Libraries, on behalf also of Tony Waldrop, Vice Chancellor for Research and Economic Development, and Carol Jenkins, Director of the Health Sciences Library

05/29/2008 at 03:42:57 PM

Goetsch

Lori

MLS

Kansas State University

Manhattan

Kansas

USA

Representative NIH Funding Recipient Organization

Question 1: I am opposed to the alternative proposal for NIH to serve as a dark archive with lines to publishers' web sites. This does not achieve the goal of creating an open access research archives.My

Question 2: Institutions like my own have already committed to compliance as currently outlined, and the library is part of the effort to inform and educate our university community. I encourage efforts to develop and support automated means of deposit such as batch uploading or downloading to facilitate compliance.

Question 3: Clarify to the research community that this policy does not jeopardize copyright. Also, dispel concerns that open access, and this policy in particular, harms the bottom line for journal publishers. Speaking as a member of the library community, it is both unrealistic and not in anyone's best interest to seriously think that massive journal cancellations would ensue as a result of this policy. Embargo periods provide sufficient safeguards to the revenue streams of publishers, and our goal as librarians is to get the relevant research our faculty need and demand out to them in a timely manner through continued subscriptions.

05/29/2008 at 03:27:59 PM

Hair

William

BS, MDiv, MLS

Baylor University

Waco

TX

USA

Representative NIH Funding Recipient Organization

Question 1: I am aware of a proposal for an alternative implementation of the Public Access Policy, where NIH would act as a dark archive and provide links to publishers' Web sites. This proposal would not achieve a major goal of the NIH, which is to provide a permanent, stable archive of its research. For a database to be effectively curated and for the quality of material it contains preserved, it must be used regularly.

Libraries have a long history in dealing with archiving and preservation issues, and can say emphatically that a dark archive that links to publishers’ Web sites is an unacceptable alternative that NIH has consistently and wisely rejected.

05/29/2008 at 02:59:36 PM

Baker

Shirley K.

MA, MA

Washington University

St. Louis

MO

USA

Representative NIH Funding Recipient Organization

Question 4: It has been brought to our attention that there an alternative has been proposed for implementation of the Public Access Policy. This alternative would have NIH as a dark archive with links to publishers' websites. The permanent, stable archive for research is a major goal of the NIH policy and would not be achieved by this alternative proposal. To guarantee permanence, a database must be used constantly and curated carefully. Libraries have a long history in archiving and preservation issues, and we can say emphatically that a dark archive that links to publishers’ websites is an unacceptable alternative that NIH has consistently and wisely rejected.

Shirley K. Baker Vice Chancellor for Scholarly Resources and Dean of Libraries Washington University in St. Louis

05/29/2008 at 02:32:50 PM

Van Kampen

Doris

EdD

Saint Leo University

New Port Richey

FL

USA

Representative NIH Funding Recipient Organization

Question 1: To provide a permanent, stable archive of NIH's research, including all grant funded entities it is critical that NIH be in charge of and accountable to the tax payer and to the research community. Vendors are bought out; journals go under; links are ephemeral. If the NIH is reponsible for all aspects of the open archives there will be a permanent record available. If this is left to the entrepreneurs, the vendors, and the individual researchers, documents will go missing, vendors will be bought out or go under, and researchers will eventually turn their interests to other topics or leave this earth, with the record of their research going into the limbo realm of orphan works, or worse yet, completely disappearing. ERIC was a commercial product, funded in part by tax payer dollars; that in and of itself is a reminder as to what happens when the only record is in the hands of the commercial sector. Is that what we want to have happen to our research tax dollars, and to research information which may be critical to our understanding of cancer research, Parkinson's research, or other medical research???

A dark archive is no archive; it is a temporary measure which will eventually be scuttled. NIH needs to mandate an open archive, with open access.

D Van Kampen

05/29/2008 at 01:25:46 PM

Newman

Kathleen

PhD

University of Illinois Library

Urbana

IL

USA

Representative NIH Funding Recipient Organization

Question 1: I have heard that there is a proposal that PMC become a preservation archive, unaccessible to all except in a cataclysm. And that instead of making papers available directly from PMC, links to the publisher's websites be made available, instead. This is totally not within the spirit or meaning of the law whereby biomedical literature was to be made freely and publicly available to all. Merely pointing to a publishers site does not guarantee that the paper will be openly available, nor that it will be available for all time (publishers frequently merge, buy titles, etc.)

An advantage I can see to this proposal is that the reader would truly have access to the absolute final, published version of the paper, as opposed to, in some cases, just the penultimate version of the paper. But I think studies currently underway will show that this is not a huge problem, and thus do not override the guaranteed availability of the research findings.

Question 2: I think the current plan of tying compliance to the possibility of obtaining future grants is adequate.

Question 3: We have set up a support site for our local researchers, http://uiuc.libguides.com/NIH. The most difficult part of submitting papers is making sure that one has retained the right to do so. So that's what we focused on (Step 1). You might beef up your support of this endeavor, e.g., by pointing to the Sherpa Romeo db.

Question 4: Although some researchers have commented on how onerous the submission process is, I think instead we should focus on how many have not found it onerous and are, in fact, supportive of the process. Researchers are, by in large, interested in sharing their research. PMC provides an elegant method for doing so. I look forward to the time when all funding agencies require that the fruits of their money be freely available. I hope work is underway to create, at least, a government-wide research archive!

05/29/2008 at 12:53:47 PM

Butter

Karen

ML

University of California, San Francisco

San Francisco

CA

USA

Representative NIH Funding Recipient Organization

Question 1: The current policy relies upon a 12 month embargo to preserve the financial interests of publishers. Moving to a 6 month embargo would better serve the interests of taxpayers without harming publishers. As one example: immediate availability of physics pre-prints has not harmed the market for physics journals. More generally, the demand of researchers for access to the latest research effectively guarantees that libraries will not carry out widespread cancellations. Another benefit of a 6 month embargo is that it aligns NIH policy with those of other respected funding organizations such as the Wellcome Trust, the European Research Council, and the Canadian Institutes of Health Research.

Simplified procedures are essential to identify compliance policies by journal title. For the future we look forward to publisher’s submission on behalf of their authors and urge NIH to collaborate with publishers in this regard. In the interim we strongly encourage NIH to partner publishers to produce a searchable index by journal title. The limited list by publisher is of little value to authors who do not know publishers nor does it include the majority of journal titles.

Question 2: Citing the PMCID in regular grant reports and new grant proposals is an effective step toward monitoring compliance with the Public Access Policy.

One way to increase incentives for compliance is for NIH to collaborate closely with campus research officers, who have more direct contact with researchers. Whenever an article from any institution is successfully deposited in PubMed Central or the NIHMS, the appropriate campus research office should be notified.

Question 3: Guidance for how to address the following scenario would be appreciated: o How should authors deal with “one-click” copyright transfer agreements, through which they have no opportunity to negotiate for the authority to deposit their manuscripts to PubMed Central?

We commend NIH for the materials currently available on the NIH website– they have been helpful in our outreach efforts to authors and in work with the research office and for rapid response to questions about the policy. Below is a summary of activities to date at the University of California, San Francisco (UCSF) and those planned for the near future: o Development of a prominent page about the NIH Public Access Policy on the Library’s web site: http://library.ucsf.edu/research/scholcomm/nih.html; o Targeted outreach to faculty, in coordination with the UCSF Office of Research; o In-service trainings for Library staff members to become familiar with the basics of the policy. These trainings rely upon the “Public Access Training” presentation developed by NIH; o Collaboration on educational and advocacy activities across the ten 10 University of California campuses; o External trainings for UCSF faculty and staff about the policy; and, o Establishment of an email address that UCSF researchers or administrative assistants can use to submit questions about the policy

Question 4: The NIH Public Access Policy has afforded an excellent opportunity for the Library to educate researchers about the extensive copyright protections they enjoy as authors. Copyright is not under attack because of the NIH Policy, but just being utilized in a different way. Rather than casually signing these protections away as a condition of publication, authors must now assert their copyright in recognition of funding by taxpayers.

Given the significant commitment of local resources allocated to support compliance with the NIH Public Access Policy, and the stated aims of the policy, we feel that the policy should remain stable for the next year at least. (However, as stated above, a shortening of the embargo period to 6 months would be preferable.) This policy is the first of its kind in the United States, and it would be distressing to see it scaled back significantly so soon after it was enacted.

The NIH Public Access Policy balances the legitimate interests of publishers with wide dissemination of the results of taxpayer-funded research. Deposit of the final peer-reviewed manuscript in a respected archive such as PubMed Central—with its easy linkages to sources of genomic, clinical, and chemical information—will facilitate scientific research and improve public health. I fully support the goals of the NIH Public Access Policy.

05/29/2008 at 12:51:22 PM

Courtois

Martin

Master of Arts Library Science

Kansas State University

Manhattan

KS

USA

Representative NIH Funding Recipient Organization

Question 1: Public access needs to separated from publishers' business models. The present implementation is sound, but all embargo periods should be eliminated. Publishers fear that immediate access will threaten subscriptions, but they should remember that libraries have been canceling subscriptions for decades, and publishers are still in business. Those people who need (and who can afford) subscriptions will not cancel them simply because an article is freely available online.

Question 2: Authors/PIs should be responsible for ensuring compliance. Future funding should be contingent on compliance.

A possible avenue for compliance may exist by having authors submit to their academic institution's repository, then export those records and items to NIH. A researcher's local institution may be able to provide assistance with compliance, although this does raise some technical concerns about importing items from various repository platforms.

Question 3: The information available is helpful, even tho it is a lot to digest.

Question 4: As publishers bring their business concerns to this discussion, it's important to remember that publishers are not the "peers" in "peer review." Publishers provide useful administrative functions, but scientists and researchers are the ones who provide the essential service of peer review.

05/29/2008 at 12:19:39 PM

Cameron-Vedros

Crystal

MLS

Univesity of Kansas Medical Center

Kansas City

KS

USA

Representative NIH Funding Recipient Organization

Question 1: We are aware of a proposal for an alternative implementation of the Public Access Policy, where NIH would act as a dark archive and provide links to publishers' Web sites. This proposal would NOT achieve a major goal of the NIH, which is to provide a permanent, stable archive of its research. For a database to be effectively curated and for the quality of material it contains preserved, it must be used regularly.

Libraries have a long history in dealing with archiving and preservation issues, and can say emphatically that a dark archive that links to publishers’ Web sites is an unacceptable alternative that NIH has consistently and wisely rejected.

Question 2: Consider developing routine communication process with campus offices of research to collaborate on ensuring compliance Consider automatic notification to be sent to the campus office of research when an article from that institution has been deposited into PubMed Central Consider automatic means of coordinating manuscript deposit between PMC and institutional repositories, possibly in batch uploads or downloads. (Indicate if you or your institution would be willing to help facilitate). Make sure that, in all future grant NIH applications, the application form or electronic submission includes a field requiring citation to all previously required PubMed Central deposits; failure to cite would be considered reason to return the application as incomplete

Question 3: Researchers would like the NIH feedback forms requesting the PI approve submitted manuscripts to be cc'd to all authors and other submitters who are listed in the submission process. Researchers realize that PI's and authors come from all numerous institutions and having all parties automatically copied to all email correspondence to and from the NIH submission process would help keep all parties involved and informed of status.

Question 4: The A. R. Dykes Library of The University of Kansas Medical Center has developed a web site containing helpguides to the NIH submission process. Library staff are presenting informational sessions and communicating the message of public access to public funded research results. See our website and recorded training events: http://www2.kumc.edu/copyright/NIHPublicAccessPolicy.html

http://www2.kumc.edu/comptraining/events.html

05/29/2008 at 12:12:03 PM

Mower

Allyson

MA

University of Utah

Salt Lake City

UT

USA

Representative NIH Funding Recipient Organization

Question 1: Institutional repositories, similar to publishers/journals, could be used a source of content.

Question 2: The current method seems sufficient.

Question 3: N/A

Question 4: Public access is essential! The results of publicly funded research needs to remain open to the public. PMC should NOT be a dark archive with only links to publishers web sites. The role of NIH and NLM is to preserve biomedical literature and merely providing links does not constitute preservation. A file along with description is required and libraries such as the NLM can provide this professional work.

Question 1: Taylor & Francis and Informa Healthcare are part of the Academic and Scientific Division of Informa plc, which provides specialist, high value information to the global Academic & Scientific, Professional, and Commercial markets via Publishing, Events and Performance Improvement.

At the heart of every Informa product and service is research-based knowledge and information for a highly targeted expert audience. Informa publishes approximately 2,500 subscription based products and services delivered both electronically and in hardcopy, and 45,000 books.

Each year Informa produces over 12,000 events around the world powered by a marketing database of over 20 million contacts. Informa operates in over 80 countries, employing more than 10,000 people. 2000 of these employees are US citizens.

We are grateful for the opportunity to respond to the National Institutes of Health (NIH) request for information regarding its Policy on Enhancing Public Access to Archived Publications Resulting from NIH Funded Research (the NIH Public Access Policy).

Response:

1) NIH should establish a formal and ongoing consultative mechanism between NIH and publishers in which NIH and publishers commit to attaining a balanced implementation of the policy that achieves the public access objectives without a negative impact on peer review and other scientific publishing. The Senate committee report (110-107) to the fiscal year 2008 Labor Health and Human Services (LHHS) Appropriations bill directed NIH “…to seek and carefully take into account the advice of journal publishers on the implementation of this policy.” In addition, the Senate report highly encouraged “…collaborations with journal publishers that would enable them to deposit manuscripts on behalf of the funded investigator, if all parties agree.”

2) NIH should follow its Congressional mandate to receive a copy of final, peer-reviewed manuscripts and work with publishers to create a robust, distributed electronic network which openly and clearly displays links from unedited manuscripts in PubMed Central (PMC) which have not yet benefited from the final copyediting, fact-checking, and proofreading required for formal publication to a final authoritative version available either from the publisher’s website or, if publishers agree, from PubMed Central.

NIH should further work with publishers to enhance the MedLine/PubMed Central web site to enable full text searches of articles on the journals’ own websites. Such searches would yield links to finished articles on those websites rather than access to manuscripts as PMC now provides. Such a comprehensive search engine would do for biomedical research what search engines such as Google and Yahoo do for the web as a whole. We urge NIH to revisit this approach because it has a number of advantages to all parties.

For NIH, this arrangement would make it possible to search the text of all biomedical research articles and not just the 10% that are based on NIH-funded research. Journals, and especially high-quality journals that publish a significant proportion of NIH-funded research, would still be able to determine their own access policies within a 12-month window and based upon their own cost recovery requirements. Finally, and perhaps most importantly, instead of access to manuscripts, this would make it possible to locate the final copy-edited articles of record presented in context with links to related materials such as commentaries and corrections.

In working with publishers to pursue this alternate implementation of its Public Access Policy, NIH should consider the example of the America Competes Act (ACA) of 2007 which shows how the goal of public access to government funded research can be solved in a way which does not endanger the intellectual property rights of private industry, its support for peer review, and the integrity of the scientific record. Section 7010 of the ACA states: The Director (of the National Science Foundation) shall ensure that all final project reports and citations of published research documents resulting from research funded, in whole or in part, by the Foundation, are made available to the public in a timely manner and in electronic form through the Foundation’s Web site.

Question 2: NIH should establish a formal and ongoing consultative mechanism between NIH and publishers in which NIH and publishers commit to the following specific compliance goals:

1) Ensure that individuals post the correct manuscript version to PMC to be publicly available at the correct time, consistent with publisher agreements 2) For publishers who submit manuscripts directly into PubMed Central, ensure that articles will not be accepted from individuals or entities other than the publisher 3) Create and disseminate to publishers detailed and robust PMC bibliographic usage statistics to monitor and identify piracy and other inappropriate usage of manuscripts and other copyrighted material posted on PubMed Central 4) Identify and implement specific safeguards to prevent copyrighted material available on PMC from being altered, pirated, made into derivative works, redisplayed, republished, resold or used for any other commercial purpose 5) Establish specific procedures, including notification of publishers, that will be implemented if piracy is discovered as a result of downloading content from PubMed Central 6) Ensure that the Policy is, and continues to be implemented in a manner consistent with copyright law

Question 3: • Regarding Copyright: We strongly urge NIH to consider public access requirements fulfilled when publishers make articles substantially funded by NIH grants available without charge immediately on publication on the publishers’ own open Web sites.

• Regarding Patent Rights: Has NIH fully considered the public-access requirements’ impact on patent rights? Articles may be jointly authored by NIH-supported and privately supported researchers – indeed, some industry researchers also receive NIH grants. Posting of accepted manuscripts to PubMedCentral may well be considered publication, imposing time limits on commercial collaborators’ ability to file patents on their inventions. Unless authors are fully aware of these implications, public-access posting could jeopardize researchers’ ability to patent and commercialize their inventions. These requirements could, moreover, jeopardize NIH-funded researchers’ access to non-NIH-funded collaborations. This would be have a negative impact on innovation and commercially exploitable scientific knowledge.

The Professional and Scholarly Publishing Division of the Association of American Publishers and the DC Principles Coalition have prepared and submitted a thorough list of the information and communications related to the NIH Public Access Policy that would be helpful to publishers. We agree that these questions should be fully and publicly addressed by NIH.

Informa supports the Association of American Publishers’ request for information and communications, which are as follows:

1) Regarding Consultation with Publishers, Societies and Authors

• Many investigators are not aware of the new policy. Does NIH have a formal mechanism and the necessary resources to handle the questions that will arise from authors and journals? • What is NIH’s timeline for amending this policy moving forward? • What mechanism will NIH put in place to continue the dialogue with publishers that will help ensure this policy is “implemented and steered” effectively and that publisher concerns are addressed?

2) Regarding Copyright

• Why hasn’t the NIH supported the full value of copyright and its use in business models including those which involve driving traffic to a publisher site, and permit linking to publishers’ web sites, rather than requiring deposit at PubMed Central?

3) Regarding Brand Protection, Repurposing and Piracy

• What mechanisms will NIH put in place to ensure that any revisions to copyrighted materials such as reformatting, enhancing, linking or otherwise changing the articles respect the integrity of the copyrighted content it receives? What assurance will NIH give that this will be done in accordance with guidelines agreed to with publishers? • Will NIH identify precisely how manuscripts will be linked to databases and other resources, and which databases? Publisher concerns about links include: a) would links within the article obscure the information in the text? b) Would it change the editorial emphasis by seeming to suggest that certain information within the article is more important than other information, simply because there is a link? c) Would it be appropriate to change that emphasis in the context of the research and the article’s focus? • How will NIH ensure proper protection of publisher or society trademarks and branding? There been no affirmation of these markers of quality, and often branding information is missing, potentially misleading users to the erroneous conclusion that the NIH is claiming copyright, or that the content is in the public domain. • How will NIH respect the rights of copyright holders and stipulate what NIH will or will not allow related to third-party use of its works? Will NIH, for example, ensure that manuscripts are not distributed to other sites around the world besides PubMed Central? Will NIH implement guidelines that explicitly prohibit third parties from exploiting content that appears on PMC without the consent of the publisher? • How will NIH prevent piracy of the articles from PubMed Central? Will NIH prevent copyrighted material available on PMC from being altered, pirated, made into derivative works, redisplayed, republished, resold or used for any other commercial purpose? What will happen if piracy is discovered as a result of downloading of content from PubMed Central and will NIH notify publishers? • If deposited content will be “mirrored” to other sites outside the U.S., after publisher approval, how will the sites be established, and how would national and international copyright considerations protect rights holders? What guidelines will NIH agree to with publishers before any distribution of copyrighted content occurs on PMC international mirror sites?

4) Regarding Compensation

• What latitude will NIH have in negotiating terms and conditions directly with publishers and other rightsholders who might wish to undertake direct licensing arrangements with NIH that would enable the deposit of copyrighted works on behalf of authors? Given that NIH’s policy would amend many journal copyright policies and effectively reduce the value of those rights, will NIH be empowered to negotiate such licensing terms, including publication charges/payment, as certain non-government funding agencies have done? • The policy provides for publisher deposit of final peer-reviewed manuscripts on behalf of authors, and includes allowance for grantees to use grant funds in the payment of publication fees. How will such funds be identified in the grant and what has NIH budgeted per year for such costs over the next five years?

5) Regarding Scope

• If other public or private funders support research also supported by NIH, what will researchers be expected to do if these other sources oppose the posting of their funded work on PubMed Central? • Will NIH agree to stipulate that its requirement for the deposit of peer-reviewed manuscripts in PubMed Central only applies when NIH funding represents substantial funding for the research on which the scholarly work is based? • The policy also holds that “Principal investigators and their institutions are responsible for ensuring all terms and conditions of awards are met.” Yet, this includes the submission of articles that arise directly from the investigators’ NIH-funded research even if they did not author or co-author the publication. In fact, NIH-funded investigators and institutions are being held responsible for making sure these other authors are “aware of and comply with” the NIH policy. How could they comply with this provision? • What will the repercussions be for investigators and journals that do not follow the process? • NIH’s 2005 voluntary policy stated that it did “not apply to contributed book chapters, editorials, reviews, or conference proceedings.” Rather, it applied “only to peer-reviewed research publications.” Will NIH modify its guidelines to state that its deposit requirement only applies to peer-reviewed manuscripts that report findings of empirical research and does not apply to literature reviews?

6) Regarding Integrity of Research, Quality Control and Meaningful Public Access

• How will the NIH know the final month of publication when the month is not always established upon acceptance to a journal? • Many manuscripts currently appear on PMC in violation of publisher policies. How will NIH ensure under the new public access policy that individuals post the correct manuscript version to PMC to be publicly available at the correct time, consistent with publisher agreements? Will NIH ensure that embargo and posting policies are implemented on a journal-by-journal level or at least publisher-level? Will NIH provide a detailed description of the process at NIH to monitor and ensure prompt take-down of manuscripts improperly submitted? • For publishers submitting directly, how will NIH ensure that manuscripts will not be accepted from individuals or entities other than the publisher? • How will NIH ensure that researchers are not misled as to the accuracy and validity of manuscripts on PMC? Will there be pointers to final published versions on publisher sites? Will NIH to develop, for example, a special section within PMC for members of general public/patients to “land” on suitable information for patients and “disclaimers” that the PMC author manuscript represents only a small part of the literature, with references and links to voluntary health organizations (VHOs), Patient Inform, publisher sites? • How will NIH deal with plagiarism and ethics issues? Will NIH establish guidelines in consultation with publishers on how to deal with corrective notices, corrigendum, and retractions?

7) Regarding Cost

• NIH faces funding shortages from the federal government. How much will it cost to effectively implement this policy? • Does this cost detract from funds to grantees actually conducting the innovative research that advances science?

8) Regarding Measuring Impact and Effectiveness

• Will NIH provide publishers with detailed and robust PMC bibliographic usage statistics that will enable them to assess the impact of PMC usage on their subscriptions? • What oversight or governance will monitor whether NIH’s performance in pursuit of its intended purpose a) is met; b) is not costly for the taxpayer; c) is not burdensome on research investigators; or d) does not have a negative impact on the integrity of the scientific and medical literature (e.g. errors and versioning problems introduced, economic harm to journals and publishers)? • What steps will NIH take if it is found that its Public Access Policy is hurting rather than advancing scientific research?

Question 4: As a trusted partner of the international research community and an indispensable link in the pursuit, distribution, preservation, and usage of scientific discovery and knowledge we appreciate the NIH’s vision for an interconnected world of science and support efforts to enhance public access to scientific research. Our investments have made more information available to more people in more ways than at any time in human history and we continue to innovate. Like other publishers, we are experimenting with data mining and visualisation tools, semantic web applications, online navigation aids, flexible displays, free access to the recent archive of published articles, and Web 2.0 applications. We are also actively supporting the development of international standards to enhance online publications and websites and maximise the discoverability of science.

This investment of resources has created and continues to fuel a system of scholarly communication which is vital to the advancement of science and the determination of critically important personal and professional rewards for scientists throughout the world. While we appreciate NIH’s pledge to work constructively with publishers to fully address copyright concerns and make the policy work, we are troubled by NIH’s lack of concern for any dislocation that will result from adhering to NIH’s “implement and steer” approach for the major shift in policy from voluntary to mandatory submission. Improper implementation of this sweeping mandate has serious implications for all stakeholders in the research community (publishers, authors, and the public) and for science itself. It is important that these implications be fully considered and addressed as soon as possible and we welcome the opportunity to work with NIH to establish the kind of productive ongoing dialog that we feel will best serve the public interest.

05/28/2008 at 05:48:50 PM

Reichel

Mary

Ph.D

Appalachian State University

Boone

NC

USA

Representative NIH Funding Recipient Organization

Question 1: The Public Access Policy is an effective move in the right direction, yet changing the embargo from 12 to 6 months would make a crucial impact on health sciences research and discovery. Our campus would not cancel journals as a result of the policy whether a six- or twelve-month embargo is in place. However, a shorter embargo time will help accelerate the dissemination of knowledge, contributing to important scientific and medical findings among partners who do not currently have access to this type of information due to cost restrictions.

Question 2: Our library’s effort in informing more faculty about copyright and developing an institutional repository will work in tandem with the new Public Access Policy as we help to spread awareness of the policy and its importance. In most colleges and universities the library, as well as the institutional Office of Research would be a nexus of information about copyright and granting-agency policies, and help to ensure compliance with the new rules in a clear, consistent fashion.

Question 3: As health science issues grow increasingly important to North Carolina. My university is developing a health sciences college and new degrees and programs to satisfy the need for health care professionals and top-tier research. Any ongoing communication about the NIH Public Access Policy would not only help ensure our compliance as potential grantees, but help us communicate the value of PubMed as a repository for peer-reviewed, taxpayer-funded research. Though North Carolina is well-known for its excellent support of education and research, our faculty throughout the state system need access to more information in order to speed the process of healthcare discovery and cures.

Question 4: I would like to express appreciation for NIH’s willingness to engage librarians, university administrators, researchers, and other stakeholders in the shaping of the Public Access Policy and encourage the NIH to continue to strongly support the new policy and implementation as currently articulated. The Policy is an excellent example of government doing the right thing to speed medical knowledge and discovery around the world.

05/28/2008 at 04:17:55 PM

Sacks

Susan

PhD

Joint Policy Committee of the Epidemiology Societies

Nutley

NJ

USA

Other

Question 1: I am the current chairman of the Joint Policy Committee of the Epidemiology Societies. We represent 14 epidemiology organizations and would like to provide comments on this policy. I am writing to request a 6-week extension to provide comments as we only recently were alerted to this webpage and we need to obtain feedback from our individual societies before we can submit a set of comments from the Joint Policy Committee as a whole. Please let me know if it will be possible to have this extension. If so, will this website continue to be active so that I can submit the comments to this website. Thank you very much for your consideration.

05/28/2008 at 04:00:29 PM

Galea

Sandro

MD, DrPH

University of Michigan

Ann Arbor

MI

USA

NIH-funded Investigator

Question 1: The current policy offloads a lot of responsibilities on the investigator. It seems that investigators have one of two options, neither entirely optimal. First, we can upload manuscripts (after seeking permission from the publisher) that are pre-prints, and hence which may be not identical to the post-print published by the publisher. Second, we can pay rather high fees to the publisher for public access. Neither of these options are ideal.

Clearly a far more desirable option would be for publishers to have an understanding that allows public access to the final, published version, of NIH-funded manuscripts that satisfies the desire for public access to these manuscripts. Perhaps a read-only repository could be established? Or a way for download of temporary files? Either way, the current system, requiring either the creation of an imperfect parallel track of manuscripts or the payment of rather large sums of money by the investigator seems subpar.

Question 2: The integration of PMIDs in progress reports and the links between PMIDs to the public repository should take care of compliance. It is hard to see how an NIH funded investigator can get around this.

Question 3: The information that is available for this has been filtered through many different Universities, often couched in legal language that is not terribly useful for day-to-day purposes. For example, our institution recommends ensuring that the publisher accepts the NIH open policy. This, once again, shifts the onus to the investigator and clears all large bodies (NIH, publishers, universities) of potential liability. Clear, unequivocal guidelines (step-by-step) about what investigators should do, and clear explication that doing so does not put the investigators in jeopardy from either NIH or publishers would go a long way to clearing the confusion around this new policy and to ensure compliance.

Question 4: No.

05/28/2008 at 03:16:13 PM

Adler

Prudence

MLS, MA

Association of Research Libraries

Washington

District of Columbia

USA

Other

Question 1: ARL encourages NIH to reconsider the current embargo period of 12 months. An embargo period of 6 months or less is more appropriate as a 12 month embargo is too long a delay for individuals to access needed research information. Research libraries will not cancel needed STM journal subscriptions if a 6 month embargo is implemented. Finally, given that scientific research is global, a 6 month embargo is more consistent with international public access policies.

Question 2: It would be helpful if NIH posted and routinely updated a list of publishers whose author agreements permit authors/institutions to comply with the NIH Public Access Policy. It would also be helpful if NIH could automatically notify the appropriate campus entity ( e.g. Office of Sponsored Research, the Library, etc.) when a manuscript or article has been deposited in PubMed Central (PMC). Finally, it would be helpful if NIH would work with academic institutions on coordinated manuscript deposit between PMC and institutional repositories.

Question 4: These comments on the revised NIH Public Access Policy are submitted on behalf of the Association of Research Libraries (ARL). Public support for science is enhanced when the public sees the benefits from our Nation's investment in scientific research. There is no doubt that scientific research is advanced by greater access to and dissemination of knowledge and the building upon the work of others.

ARL commends NIH for soliciting additional comments on the revised Policy while at the same time, implementing the congressionally approved change in policy. Because the NIH Policy is integrally tied to the mission of higher education, research libraries are collaborating with others across the academic enterprise to ensure effective compliance with the revised Policy. This entails assisting individual researchers, working with campus research offices, developing or extending existing policies to ensure effective compliance, creating informational websites and more. Copyright management and access have been the focus of ARL libraries for quite some time. This involves helping authors make informed decisions so that they exercise their rights and interests in the ownership and use of copyrighted works in a manner that promotes the greatest possible scholarship and public use of their work. As a result, implementation of the NIH Policy builds on existing policies and initiatives and is seen as one more opportunity to support the interests of the academy.

05/28/2008 at 02:29:45 PM

DeCrappeo

Anthony

Council on Governmental Relations

Washington

DC

USA

Representative NIH Funding Recipient Organization

Question 1: Much of the burden of meeting this statutory requirement would be eased if more journals would collaborate with the research community in meeting the statutory obligation. The most effective way to meet this obligation would be if publishers modify standard copyright agreements to include a provision that acknowledges that the author retains the right to provide a copy of the final peer-reviewed manuscript to the NIH and to make the article available in PubMed Central (PMC) no later than 12 months after publication by the journal.

As an alternative, journals could agree to deposit the final published article in PubMed Central. In this case, a significant portion of the burden on the grantee institution and its investigators is relieved and the public has timely access to the results of federally supported research. We recognize that the business models for many of the professional society-based journals do not anticipate this approach. Nonetheless, the society members are the very investigators that will be unable to meet their grant obligations and, as a consequence, jeopardize future federal funding.

Conversely, NIH can assist the research community by reconsidering its strategy for meeting its obligations under the Consolidated Appropriations Act of 2008. The language in the statute does not preclude NIH from providing links to journal websites as a way to make research results publicly available. There is no apparent expectation for a permanent archive of publications, per se, or a prescribed format for the publicly available electronic versions. A link to journal websites can meet NIH’s obligations under Consolidated Appropriations Act.

Question 2: The process for monitoring compliance with the policy is built into the policy itself. The requirement for a PMC or NIH Manuscript Submission number on references included in applications, proposals or progress reports will serve as a useful reminder and monitor. Over time, these submission to PubMed Central will become a usual and customary part of process of article publication. We would urge NIH to avoid building a more elaborate monitoring mechanism and rely on the slow but inevitable change in culture.

The near-term problem will be how to address the compliance question with investigators who inadvertently fail to reserve their rights to submit to PubMed Central. We hope that NIH will recognize that this transition will take some time before it is complete. Institutions and investigators will not want to be forced into a position to violate signed copyright agreements

Question 3: Our concern remains grounded in the nature of the institution’s relationship – or lack thereof – to the process of publication. Normally, institutions do not join in the relationship between authors and journals. However, as the grantee, a research institution is obligated to meet the terms and conditions of all its agreements. As such, institutions must act to ensure compliance with this NIH requirement. We will remind our investigators to maintain their rights individually to provide a copy of the final peer-reviewed manuscript that has been accepted for publication to PubMed Central (PMC) under current copyright law provisions. We will provide them with proposed language to insert in copyright agreements to enable posting to PMC. With respect to our subrecipients, we will include the requirements of the Public Access policy in our subagreements.

Question 4: COGR offered comment at the public meeting on March 20, 2008. We noted our responsibilities to assist our investigators to meet our shared obligation and expressed our appreciation for the resources that NIH has made available on its web site directed to this issue.

As NIH has moved forward with this policy, investigators have discovered the significant costs of providing public access. Journal charges for public access for a single article have reached, in some cases, $3,000. NIH has reminded the community that publication charges are an allowable expense against a grant. However, charging these publication costs to a grant will result in a considerable reduction in funds available to conduct research.

Moreover, we expect that in many cases publications will be accepted after a grant has closed. As a result, research institutions will be expected to assist investigators in meeting these unexpected costs, putting greater strain on institutions that currently provide more than 20 percent of the funds to conduct research in the US. Combined with increasing unfunded compliance costs for the institutions and reductions in NIH’s budget, in general, this policy will contribute to a real reduction in funds available to conduct biomedical research.

We remain concerned for investigators – particularly junior investigators – whose career advancement may be jeopardized if some journals refuse to accept the reservation of rights or the investigator lacks access to sufficient resources to pay the price for public access. We hope that NIH will continue to engage the publishing community in discussions that seek a resolution of outstanding issues including cooperation in the reservation of rights to submit to PMC and fees associated with providing public access.

Question 1: Many publishers, especially not-for-profit publishers, make ALL of the final content of their journals available free at 12 months. These publishers have offered many times to have PubMed and/or PubMedCentral link to these final articles on the publishers' websites and to implement links from those websites to other NLM databases. Implementing this linking would save thousands of researchers from having to load articles on PubMedCentral because the publishers already load the articles on their websites. These publishers' websites are stable, archived, and are permanently available worldwide. Further, linking would ensure that there was only one version, the final and best version, of an article available to the public. Minimally, the mandatory deposit requirement should be waived for authors who publish in journals that make their articles available free online at 12 months or less. The NIH policy reflects a basic misunderstanding of the Internet--an article that is available online free on a website IS available to everyone. The mandatory deposit on PubMedCentral policy should apply only to articles reporting NIH-funded research that are not made freely availble by publishers. Double deposit of different versions of articles is wasteful, redundant, and potentially dangerous to the public.

Question 2: There is no way NIH will be able to monitor effectively the quality of thousands of deposited manuscripts without checking them against a final version on a publisher's website. Such version comparison cannot be automated and would require considerable human resources. There already exist on PubMedCentral papers that should not have been deposited under the previous mandatory policy (too old, wrong versions, not allowed by copyright agreements, etc.). If errors could not be monitored when there were only several thousand papers deposited under the voluntary policy, how could NIH monitor an eventual hundreds of thousands? Compliance would require sanctions to be available, such as lawsuits, fines, withholding grants, or reporting to institutions if a researcher: 1. Fails to load the papers within the timeframe required. 2. Makes mistakes in loading papers (partial text, etc.) or has serious text mistakes in the PMC-loaded papers (later corrected by copy-editing). 3. Publishes in a journal that does not allow deposit in PMC. Is this the role NIH wishes to assume: to punish researchers? If so, how much will NIH spend in becoming a watchdog of author compliance? Will NIH refuse to fund promising research that might lead to cures because the researcher previously failed to load an article on PMC? Consequences for complying with this mandate may cause more harm to the public than noncompliance.

Question 3: If the articles on PMC are to be a public service, then there needs to be instruction to the public on how to interpret an animal study, a study with an insufficient number of subjects, a report of an experimental new drug that has not been proven in a trial, a phase 1 study versus a phase 3 study, etc. Also, there needs to be a VERY CLEAR warning that the articles in PMC are not final articles and do not represent all of the literature on a topic. For the public or anyone, a fragment of the literature could be a dangerous thing, and an unedited article could also be dangerous. There are few if any warnings on PMC now.

Question 4: The NIH public access mandate was made possible by convincing a few members of Congress that people were suffering and dying because publishers charge fees for subscriptions to journals. Free the literature and all will be possible, went one open access advertisement. Science deals with proof, and where is the proof that free journal articles will do anything? People are suffering and dying because there are no cures for some diseases; because even when preventive measures are possible they aren't applied (eliminating smoking will save lots of lives); because so many have poor or no access to medical care, including the over 47 million people who are uninsured in one of the richest countries in the world. Now that rich country is cutting research funding when other countries are increasing theirs. Surely more people will suffer and die because research funding is being cut than will ever be affected by access to any or all of the journal literature. For the past decade the NIH's National Library of Medicine (NLM), an organization that would simply not exist were there no publishers, has been leading an attack on commercial and not-for-profit publishers while NLM seeks to become one of the largest publishers in the world, first with eBioMed, then with PubMedCentral. The irony of this is apparent. In the latest implementation of its publishing plans--the mandatory deposit policy--NLM mandates that review articles by NIH-funded authors be deposited on PubMedCentral. Review articles are not original research and therefore not funded by research dollars but by publishers who commission them. They were not covered by the previous, voluntary deposit policy and never discussed by Congress. Thus the decision to require the deposit of review articles was made internally at NIH, without public discussion or legislative ruling. The NLM is funded by our tax dollars but there is no publicly available information on how much has been spent for PubMedCentral or how its effect will be evaluated. Taxpayers' assets should be put to better use than for redundancy--duplicating publishing services already provided by private funding. The real problems of health care have nothing to do with journal articles. We need more research, not more redundancy.

05/28/2008 at 01:40:09 PM

Oliver

Kathleen

MSLS, MPH

Johns Hopkins University Libraries Council

Baltimore

MD

USA

Representative NIH Funding Recipient Organization

Question 1: We believe the following suggestions, if implemented, would facilitate compliance for investigators, authors and institutions. They are • NIH could publish recommendations for authors on reserving rights with publishers who use on-line one click contracts, and • NIH could enable libraries to make submissions on behalf of faculty.

Question 2: We appreciate the opportunity to express our support for the NIH Public Access Policy and its implementation as currently stated, and supplement our expressions of support as submitted March 17. The continued engagement of NIH with its stakeholders is both wise and productive.

On May 15, 2008, the Johns Hopkins University Council of Deans voted to require Johns Hopkins University (JHU) researchers supported by NIH funds to retain sufficient rights to all papers published in the course of their NIH-sponsored research. Having retained rights to permit submission to PubMed, JHU faculty members must then submit their articles in a timely fashion. To retain rights, the Council of Deans recommended two alternate addenda and a notification letter that JHU faculty members can employ. The first addendum, http://openaccess.jhmi.edu/ADDENDUM1.pdf, constitutes the bare minimum for compliance with the NIH Public Access requirement. The second addendum, http://openaccess.jhmi.edu/AddendumToPublicationAgreement.pdf, allows faculty members to comply with the NIH requirement while retaining broader rights for their own benefit as apparent from the provisions of this addendum.

The Council of Deans voted to encourage faculty members to use Addendum 2 if possible as it is in every scholar’s interest to retain broader rights to their intellectual products. However, to assure compliance with the NIH mandate, the University requires that faculty members at a minimum use Addendum 1.

Question 3: NIH could publish recommendations for authors on reserving rights with publishers who use on-line one click contracts.

We appreciate the opportunity to express our support for the NIH Public Access Policy and its implementation as currently stated, and supplement our expressions of support as submitted March 17. The continued engagement of NIH with its stakeholders is both wise and productive.

On May 15, 2008, the Johns Hopkins Council of Deans voted to require Johns Hopkins University (JHU) researchers supported by NIH funds to retain sufficient rights to all papers published in the course of their NIH-sponsored research. To do so, there are two alternate addenda and a recommended notification letter that JHU faculty members can employ. The first addendum, http://openaccess.jhmi.edu/ADDENDUM1.pdf, constitutes the bare minimum for compliance with the NIH Public Access requirement. The second addendum, http://openaccess.jhmi.edu/AddendumToPublicationAgreement.pdf , allows faculty members to comply with the NIH requirement while retaining broader rights for their own benefit as apparent from the provisions of this addendum. The Council of Deans voted to encourage faculty members to use Addendum 2 if possible as it is in every scholar’s interest to retain broader rights to their intellectual products. However, to assure compliance with the NIH mandate, the University requires that faculty members at a minimum use Addendum 1. At Johns Hopkins University, the University Libraries Council strongly supports the NIH Public Access Policy. The new NIH reporting requirement will benefit Hopkins authors as well as the public. The requirement provides an important opportunity to make published research funded by NIH and written by Hopkins authors accessible to all - the public, health care providers, educators and scientists, among others. This improved access will help advance science and, ultimately, improve human health.

Deposit in PubMed Central ensures that research results will be preserved in a state-of- the-art digital repository. Free access within a 12-month period will maximize the visibility of Hopkins’ research and ensure that researchers and students around the world will be able to read and build on Hopkins’ work, regardless of their ability to subscribe to the journal in which the research is published. Preliminary research suggests that articles freely available are cited more often and have a greater impact than articles locked away behind subscription walls. NIH public access will foster development of new research tools, open doors to new research avenues, and advance scientific discovery. At Johns Hopkins University, we have taken the following steps in response to the NIH Public Access Policy:

1. The Dean of University Libraries, Winston Tabb, the Director of the Welch Medical Library, Nancy Roderer, and the Vice Provost for Research met to explore how the University and its Libraries can assist its authors in meeting the NIH mandate and support open access to the scholarly output of the University. 2. From that meeting came a recommendation from the Provost to the Deans that the University adopt an authors’ addendum to publication agreements, enabling Hopkins faculty to make their research results freely available through PubMed Central. 3. Created a scholarly communications website (openaccess.jhu.edu) with an FAQ on the NIH policy, including the Johns Hopkins’ authors’ addendum. The FAQ also directs authors to the SCAE, a tool to customize addenda and designed to enable authors to reserve their rights in support of peer exchange, teaching, and public access. The FAQ includes contact information for two members of the Scholarly Communications Group of the University Libraries Council, who will respond to questions from our authors. 4. Advised our Vice Deans for Research in the Schools of Medicine, Public Health and Nursing of the FAQ; remain in close contact with the Office of the General Counsel, sharing the Carroll White Paper and other relevant analysis of implications of the Policy for the University and its authors. 5. Broadcast emails from the Deans and the Provost alerting faculty to their responsibilities under the new mandate have been sent. The emails direct authors to an FAQ on the NIH Policy developed by the University’s Scholarly Communications Group. The School of Public Health and the School of Medicine have linked to the resource from their research administration sites. 6. Initiated discussions on how we might develop an interface between our repository and PubMed Central in collaboration with other institutions and software developers. At our request, the Association of Research Libraries has agreed to play a leadership role in bringing interested parties into the discussion, including the National Library of Medicine. 7. Joined fellow members of the American Association of Health Science Libraries in strong support of the NIH Public Access Policy. 8. Have conducted educational sessions on the policy and how to comply with faculty and staff across the University, and are working with our authors to ensure copyright compliance through the use of addenda to publication agreements, directing them to the NIH Public Access Policy FAQ as needed. 9. JScholarship, the Johns Hopkins institutional repository, is taking an active role in promoting open access publishing activities. The Graduate Board for the University has mandated submission of all theses and dissertations into JScholarship beginning in 2009. JScholarship personnel are currently putting in place a submission workflow to enable students to self-submit their theses into the repository. In addition, we are developing a process by which an author may make his or her work available under a Creative Commons license. We plan to promote the use of these licenses to enable the widest possible use our research materials. Finally, we have devoted a section of our JScholarship "help" pages to copyright issues. This page http://library.jhu.edu/collections/institutionalrepository/irhelppage.html offers advice to authors about copyright issues in the repository, and contains information about the SHERPA/RoMEO database. 10. In sum, the policy has created a valuable opportunity to collaborate across campus, involving faculty, libraries and academic administrators to ensure the broadest level of compliance and exposure of our research results. 11. Finally, the University Libraries Council values the services provided by publishers, and does not believe that we can cancel journals and still provide our faculty, students and researchers the current information necessary for their work.

05/28/2008 at 01:32:07 PM

ness

roberta

MD, MPH

University of Pittsburgh

Pittsburgh

PA

USA

NIH-funded Investigator

Question 1: Yes. NIH could work with journals directly, as they do through PubMed, and in that way provide timely public access to publications. In other words, rather than shifting responsibility to investigators, they could take primary responsibility for assuring public access.

Question 3: Many journals are now assessing large surcharges (in the thousands of dollars per publication) to assure compliance with the policy. Most investigators do not know that these surcharges are not mandatory. Specifically, investigators do not know that they can upload final accepted drafts, and not only the final publication directly. To the extent that many researchers believe they must pay these fees, this will have a chilling impact on students, trainees, and investigators in developing countries, as well as on any investigator that is not well funded. It is imperative that NIH clearly and concisely warn all NIH-funded investigators that they need not pay these fees and how to avoid doing so.

Imbedding this information on page 5 of a website is not adequate. A brief, clear warning should be sent to all funded investigators regarding this situation.

05/28/2008 at 12:58:30 PM

Baker

Shirley K.

MA, MA

Washington University

St. Louis

Missouri

USA

Representative NIH Funding Recipient Organization

Question 1: Shorten the embargo period to six months. Otherwise, the Policy is well crafted and should be implemented.

Question 2: Ensure that publishers cooperate with the NIH in implementation of this Policy. Monitor the information publishers are providing to authors to make sure it accurately represented the Policy.

Question 4: The Washington University community appreciates the willingness of NIH to hear from stakeholders.

The transmission of knowledge is central to the mission of Washington University in St. Louis as is research and the creation of new knowledge. The underlying principle of the NIH Public Access Policy is to disseminate scientific knowledge generated by NIH funded research for the public good. We are confident that WU can meet its obligations to fulfill the requirements of the NIH Public Access Policy.” Speaking as University Librarian, I can assure publishers that the NIH policy will not result in mass cancellation of journal subscriptions at Washington University. The delay of 12 months ensures that taxpayer-funded research ultimately becomes publically available; however our University researchers must have access to the journals without a 12 month delay. Even if the delay were only six months, we would still continue our subscriptions. The University has made the necessary arrangements to support compliance with the NIH Public Access Policy. We are revising our grant application submission form to remind investigators of their need to comply and to certify that they have met that obligation. We have also educated the research administrators so that they can help faculty comply.

In addition, librarians are meeting with faculty from all departments engaged in NIH-supported research and providing them with the assistance needed to comply with the law. At the same time, we are engaging in discussions with faculty around copyright issues, to foster an understanding of faculty rights and their obligations. The NIH Public Access Policy has provided a welcome opportunity to engage in these discussions and to encourage broad distribution of Washington University research results. Our work with faculty would be facilitated by NIH’s publishing a list of publishers whose author publishing agreements provide for deposit with PMC in a manner that is consistent with copyright law.

05/28/2008 at 12:38:31 PM

Mullaly-Quijas

Peggy

PhD

University of Missouri - Kansas City

Kansas City

MO

USA

Other

Question 1: I would recommend that the embargo be 6 months long, not 12.

Question 2: I would make this policy no different than the other policies that PIs must follow when receiving NIH funding.

Question 3: An up-to-date list of publishers that will submit manuscripts to NIH on the behalf of PIs

Question 4: I appreciate NIH asking for these comments as they implement policy. While I submitted comments before, I wanted to update my thoughts.

The new NIH Public Access Policy is a great opportunity to get NIH funded research out to my faculty and researchers to accelerate the rate of research on my campus. As a Librarian supporting those faculty and researchers, I have spent a great deal of time creating a resource to help educate the faculty on this new policy. Please see: http://libguides.library.umkc.edu/content.php?pid=5230

I understand that the largest concern with the policy from the publishers is that libraries would cancel their subscription to a journal title based on this policy. For my perspective, this is ungrounded. We do not cancel titles for this reason. The embargo alone would require we have access to the most recent journals to support our faculty. If copyright issues are a concern – though I am not sure how! – I am working to educate my faculty on their rights as copyright holders.

My only suggestion is to please consider making the embargo 6 months. Again, as a professional librarian supporting the faculty, I would not be canceling a journal because of this policy.

Question 1: On behalf of the president of the American Heart Association, Dr. Daniel W. Jones, and the chair of the AHA Scientific Publishing Committee, Dr. David Gutterman, I am submitting a letter with the AHA's response to this policy. I am the Director of Scientific Publishing for the AHA. The text of the letter is in question #4.

Question 2: Please see our letter

Question 3: Please see our letter

Question 4: The American Heart Association appreciates the opportunity to comment on the mandatory Open Access Policy. Articles in AHA journals that are original research articles are freely accessbile to all users after six months and all AHA journal content is freely available after one year. We also appreciate the NIH pledge to work constructively with publishers to fully address copyright concerns and make the policy work. However, we would like to echo the comments made via the DC Principles Coalition, our concerns are the same already put forward, and broadly include, as stated already by the DC Principles Coalition (1):

Copyright: Blanket requirements in grant contracts would effectively deny authors and publishers the benefits of their copyrights—the most fundamental of which is the ability to decide how and in what form their works may be distributed—in conflict with fundamental copyright principles and without compensation for the value added by publishers and editors. In effect, the application of the NIH policy is an imposition of an extraordinary and unprecedented exception or burden to the copyright works—and thus diminishes their value for any journal business model that relies on exclusivity to drive traffic, advertising and subscriptions. The NIH policy essentially mandates a business model that can accommodate this “burdened” copyright, a model that must be based on up-front submission or publication charges, rather than the current models of the vast majority of journal publishers. This does not seem to us to be consistent with the legislative mandate to implement the NIH policy consistent with copyright. Other alternatives to the NIH policy of mandated centralized posting on PMC can and should be considered, alternatives that would still be consistent with the legislative mandate of public access within 12 months of publication. For example, given our entire journals are free online after a year, shouldn’t NIH support the full value of copyright and their use in business models including those which involve driving traffic to a publisher site, and permit linking to publishers’ web sites, rather than requiring deposit at PubMed Central ?

Quality Control and Compliance with Publisher Policies: Many manuscripts currently appear on PubMed Central (PMC) in violation of publisher policies. How will NIH ensure under the new public access policy that individuals post the correct manuscript version to PMC to be publicly available at the correct time, consistent with publisher agreements? For publishers submitting directly, how will NIH ensure that articles will not be accepted from individuals or entities other than the publisher?

Scope: The revised mandatory public access policy now calls for submission of review articles. This is of concern to publishers especially since NIH previously encouraged us to add review articles to our journals as a way to protect our subscription base under the voluntary policy. Editors commission the review articles based on the scientific expertise of scientists; they are not based on specific research projects supported by NIH research grants. Furthermore, requiring that review articles be included will seriously undermine the many journals that publish review articles only.

Repurposing: Changes made by NIH or authors that will result in variations from the original manuscript are of considerable concern for a number of reasons, not least of which is the potential introduction of errors. NIH needs to ensure that no changes, such as substantive editorial changes, are made to the manuscripts other than obvious errors in NIH production process or perhaps improved graphics for related illustrations. Links to other databases also raise concerns about changing an article’s principal context and focus. NIH needs to identify precisely how manuscripts will be linked to databases and other resources to ensure the editorial integrity of the underlying work.

Patient education. Although we understand that the principal motivation of the legislative mandate to be patient information and education, the NIH policy implementation does not address this need directly (focusing instead on building researcher infrastructure). Publishers have been working actively with voluntary health organizations (VHOs), as you are aware, and we believe more should be done in this area by NIH, hopefully working with publishers and VHOs. We actively participate, for example, in the PatientINFORM effort.

Piracy: Third parties could commercially exploit content that appears on PMC without the consent of the publisher. What safeguards will NIH put in place to prevent copyrighted material available on PMC from being altered, pirated, made into derivative works, redisplayed, republished, resold or used for any other commercial purpose?

As stated at the beginning of this letter, these are some of the key issues that deserve continued discussion. We thank the NIH for the opportunity to comment.

Sincerely, David Gutterman, MD; Daniel W. Jones, MD

05/28/2008 at 11:09:32 AM

Johnson

Scott

PhD

Towson University

Towson

MD

USA

Other

Question 1: I am the chair of the Publications Committee of a small scientific society. Our primary function is to publish papers in a peer-reviewed scientific journal. At present, we rely on a major publisher to produce our journal. The publisher is only going to continue this endeavor if it is reasonably profitable for them. We are concerned that our publisher’s subscription revenue will decline when the public is given free access to papers published in our journal in Pub Med Central within such a short time frame. We do not understand why NIH cannot work out an agreement with publishers to establish public access to articles, through publisher’s websites, within a reasonable amount of time. Such a system would also save taxpayers and enormous amount of money.

05/27/2008 at 07:43:51 PM

Lee

Daniel

M.A., M.L.S.

University of Arizona

Tucson

Arizona

USA

Representative NIH Funding Recipient Organization

Question 1: The submission process needs to be as simple as possible, ideally as simple as emailing a reprint to a colleague. Although there are tools available to help PIs, the recommended implementation still requires an understanding of a range of publisher policies and, often, negotiation to ensure necessary rights are retained to comply with the policy. Compliance also requires following a process that is outside a normal workflow.

Admittedly, The NIH is working within a publishing environment that is not of their making and the NIH has no easy way to compel publishers to participate themselves. However, it would benefit all parties if NIH would work with publishers to increase the number who automatically submit manuscripts for funded authors. Researchers can help drive this by requesting publisher participation, but the leverage of a large funding agency reaching out to publishers will help ease the transition.

Ultimately, to have the greatest impact, NIH support should take advantage of the scientific skills of researchers rather than requiring even modest bureaucracies.

Question 2: Easing the submission process will help ensure compliance. In general, researchers want to share their results. The low rate of participation in the voluntary program is a reasonable indication that the submission process is/was seen as a barrier.

Question 3: Besides the link to a list of journals that will submit manuscripts for authors, it would be helpful to have access from the policy site to easily understood information about publishers’ policies that comply with the new policy. Other than that, a simple submission process will reduce the need for training.

Question 4: The goals of new policy and the Congressional mandate are most welcome. As noted above, researchers want to share their results. A policy that promotes broad access to these results will allow more people to benefit from the sponsored research and for others to build on prior work.

Other disciplines have a long history of sharing research results through pre-prints without having a negative impact on publishers’ ability to maintain a sufficient revenue stream and viable business models. There is no reason to expect a different result here.

Rather, this policy is an important step towards improved public access to publicly funded research. It is essential for NIH to work out practicable processes as similar policies are adopted by other government funding agencies.

05/27/2008 at 04:00:09 PM

Baker

Nancy

MLS, MA

University of Iowa

Iowa City

Iowa

USA

Representative NIH Funding Recipient Organization

Question 1: I am pleased to have this opportunity to indicate, once again, our strong support for the current NIH Public Access Policy. We believe that this policy promotes new discovery, fosters innovation, increases accountability for public funding, and makes medical research available to patients and other members of the public. These are all core to the mission of a pubic research university. At the University of Iowa, our librarians have offered small seminars on how to comply with this new policy for specific campus departments, as well as open sessions to anyone who might be interested. An informational website has been created, linking to the information at NIH. Librarians have been available to assist and consult with individual campus researchers about the submission of manuscripts to PubMed Central. The concerns offered by many who have opposed this policy remain unfounded. The University of Iowa has not cancelled any journals as a result of this policy nor do we anticipate any such cancellations in the future. Publishers of scientific journals have regularly indicated to the library community that the market for their new publications is 6 months, sometimes less. So we know that a 12 month embargo is protecting them from financial harm. Moreover a 6 month embargo would also be more consistent with terms of other countries, specifically the European Union, UK and Canada. The University of Iowa has also endorsed an author addemdum that enables faculty to retain rights to their work while giving the publisher license to publish. If NIH had information available on which publishers support such addenda, that would likely be helpful to our authors.

Question 2: As noted above, an automatic, routine process for communicating with campus research offices when an article has been deposited into PubMed Central would assist compliance. For those universities with institutional repositories, some automatic way that manuscripts could be submitted jointly deposited would be helpful. Any additional ways that NIH might make the submission of articles easier for authors in the future as technologies improve would be welcomed.

Question 3: Since many libraries link their information websites on this policy directly to NIH, it will be important to NIH to keep their electronic information on any changing procedures up-to-date.

Question 4: There is a tremendous amount of federal money that is invested into medical research each year. The NIH Public Access Policy also creates a single, publicly accessible testament to the fruits of this public investment that could potentially lead to increased public support for this critical research. Finally, I appreciate NIH's continued willingness to solicit this feedback from stakeholders.

05/27/2008 at 01:42:55 PM

St. Clair

Gloriana

Ph.D.

Carnegie Mellon University Libraries

Pittsburgh

PA

USA

Representative NIH Funding Recipient Organization

Question 2: The best way to ensure the submission of articles and the inclusion of PubMed Central reference numbers in citations is to delay or prevent the distribution of funds. When investigators see that funding will be impacted, they will comply. The recent addition to the NIH FAQ that provides information about actions the NIH may take when investigators and institutions fail to take steps to ensure compliance with the NIH Public Access Policy is very helpful in this regard.

Concerns about investigators submitting articles to PubMed Central that are not covered by the NIH Public Access Policy can be addressed through education. Concerns about investigators retaining the necessary rights to submit to PubMed Central articles that are covered by the NIH Public Access Policy can be addressed through education and by developing partnerships with more publishers so that the publisher will submit final published articles on behalf of the authors. In the absence of publisher partnerships, NIH must trust the institutions and investigators they fund to comply with the Public Access Policy - just as publishers must trust the authors they publish to comply with the terms of the copyright agreement. Institutions are working to educate faculty about their copyrights and responsibilities, including the NIH Public Access Policy and publisher policies regarding open access.

Some publishers have suggested that NIH should closely monitor submissions to PubMed Central to prevent copyright infringement. This is not feasible because only the author and the publisher know what rights were transferred and what rights were retained. For this reason only copyright owners can legally claim copyright infringement. If copyright infringement occurs in PubMed Central, the copyright owner should notify NIH and the author(s) and the infringing work should be removed from PubMed Central.

Expecting a government agency to monitor and ensure that funded authors comply with publisher copyright transfer agreements introduces a new approach to copyright law enforcement that would have implications far beyond the implementation of the NIH Public Access Policy. Serious consideration of this approach would require a much broader discussion.

Question 3: The NIH Public Access Policy is profoundly important. Public access to the results of NIH-funded research will accelerate scientific discovery and give the American public vital information. The pattern that the NIH has established for gathering input from stakeholders and addressing their concerns is to be praised.

The policy has just been implemented. Experience will indicate where clarification or modification is needed. For example, initial public comments revealed inconsistencies in the language used on the NIH website to describe procedures. These inconsistencies were a source of confusion. We are pleased that NIH responded promptly and made the language consistent. Over time, as researchers and their assistants work with the procedural information and tools provided by the NIH, other problems might surface that need to be addressed. Periodic requests for public comment will ensure that the dialog with stakeholders and the fine tuning of tools, training and documentation continue.

Question 4: Respect for copyright

In the academic environment, the original copyright owners of written works are typically the authors who conducted the research. They are free to choose what rights, if any, they want to transfer and to whom. Concerns that publisher copyrights are being infringed by the mandatory NIH Public Access Policy are unfounded. Publishers have no copyrights unless or until authors grant them rights. Furthermore publishers have only the rights that authors grant to them. Publishers must respect author copyrights and the legal authority of authors to manage their copyrights as they see fit. Publisher approval or disapproval of how authors choose to manage their copyrights is irrelevant under the law.

The NIH Public Access Policy does not introduce a new limitation or exception in copyright law, but rather constrains the contract terms to which funded authors can agree. This constraint does not constitute a compulsory license because authors as copyright owners are not legally required to permit others to use their work without permission. What they are legally required to do - if and only if they accept NIH funding - is to retain the rights necessary to deposit their work in PubMed Central.

The NIH is not the copyright owner of peer-reviewed work based on the research it funds. To comply with the legislative mandate that the NIH Public Access Policy be implemented "in a manner consistent with copyright law," NIH must look to the original copyright owners (the authors) to retain the necessary rights to comply with the policy. NIH has no authority to manage or to negotiate authors' rights. Researchers are free to seek funding from the NIH, in which case they must comply with the NIH Public Access Policy, or to seek funding elsewhere. Publishers are free to allow authors to retain the necessary rights to comply with the NIH policy or to refuse to publish the results of NIH-funded research. Requiring authors to manage their copyrights and requiring publishers to respect author copyrights are positive developments in keeping with the letter and spirit of U.S. copyright law.

Author – publisher relationships

Concerns that the NIH Public Access Policy places authors in conflict with publishers suggest that the traditional practice, whereby authors routinely transferred all copyrights to their publishers, has become so entrenched that some publishers feel entitled to the transfer of all copyrights and question or resent the authors' freedom to choose otherwise. There is no legal basis for this entitlement or questioning. The recommendation offered by some publishers that the NIH simply pay publishers for the articles rather than requiring authors or their institutions to negotiate copyright suggests that economic concerns might be driving publisher interest in retaining all copyrights.

Concerns that the NIH Public Access Policy will influence the selection of publishers are real. However the claim that this influencing is unethical masks an underlying discrepancy in operating principles presumed to be allowable for different stakeholders. Publishers understandably want to manage the copyrights granted to them by authors. All copyright owners should want to manage their copyrights. Why, then, is it problematic for authors to manage their copyrights? Under the publish or perish paradigm, authors unreflectively transferred all of their copyrights to the publisher. This paradigm is crumbling, being replaced by a publish and perish paradigm because restricted access and the cost of scholarly journals are shrinking readership. The impact advantage of providing open access to scholarly work and new metrics for evaluating the quality and influence of scholarly work are changing relationships. Authors are beginning to reflect on their copyrights and to decide what rights they want or need to retain. The NIH Public Access Policy might accelerate a trend that has already begun, but the policy did not initiate the trend. Rather, the policy results from the trend.

If indeed the list of PubMed Central (PMC) journal partners available on the NIH website encourages authors to publish in these journals (for the convenience of having the publisher submit their work in compliance with the NIH policy), publishers are free to become PMC partners. If indeed the NIH public access policy leads authors to favor journals with access policies consistent with the NIH policy, that will be beneficial. Publishers are free to change their journal policies. Competitive advantage is a key factor in the free enterprise system. Business models that lose their competitive advantage gain nothing by bucking the trends. I'm reminded of the story of the fellow who continued to manufacture buggy whips long after the horse and buggy were replaced by the automobile. His lamentations did not bring back the horse and buggy.

Publishers are understandably concerned about retaining the commercial value of their copyrights. The allowable twelve-month embargo period will protect their interests. NIH-funded researchers work in disciplines where access to the most up-to-date information is essential to their work and continued funding. They cannot wait until the embargo period is over to see the newest research results. Furthermore reviews, commentaries, and research not funded by the NIH will not be available in PMC. Subscriptions and interlibrary loan will continue to be the primary means of prompt access to this information.

The integrity and usefulness of the scientific record

Some publishers have claimed that the NIH Public Access Policy will harm the integrity and usefulness of the scientific record because multiple versions of a given article will confuse readers and because final peer-reviewed manuscripts in PubMed Central might contain errors. These conditions predate and are irrelevant to the NIH policy. Multiple versions of many articles have been available on the Internet for many years (e.g., technical reports, conference papers, pre-prints, post-prints). Furthermore even published journal articles can contain errors; errata are issued later. Certainly scholars and medical professionals know that the published article is the scientific record. The many citizens who responded to the NIH's call for comments, eager to have free access to research findings, will no doubt raise and discuss what they read with medical professionals.

NIH archive and public access

Many publishers have recommended replacing public access to peer-reviewed manuscripts of NIH-funded work in PubMed Central (PMC) with a link from PMC to the final published version on the publisher's website. However, doing this would not accomplish one of the primary goals of the NIH, which is to create a searchable archive of the work it funds. An alternative recommendation that acknowledges the importance of an NIH archive suggests that PubMed Central become a dark archive used only by NIH and NLM for administrative purposes. Other users would access the published articles on publisher websites.

The dangers of dark archives are well known. For example, a single dark archive offers a very low assurance level and requires elaborate systems to ensure that bit integrity is maintained. Currently the only efficient, affordable way to ensure the integrity and usefulness of a digital collection is to allow its use.

The dangers of relying on publisher websites for open access to NIH-funded articles are also well known. Publishers can go out of business or fail to maintain their archive. Furthermore, they are free to change their access policies. Thus the only way for NIH to ensure that the research it funds is publicly accessible and preserved over time is to maintain an active, replicated archive.

Question 1: I am supportive of an embargo period to balance our needs with those of publishers; however, I would prefer that the embargo period be reduced to six (6) months. It would synchronize more effectively with the pace of biomedical research and discovery and with policies in sister countries such as Canada, the United Kingdom, and Europe generally. We want and need to be competitive with the rest of the world. In addition, author addenda facilitate authors’ retention of their rights while allowing publishers the license to publish.

It would also be helpful if NIH could publish a list of publishers whose publishing agreements with authors provide for deposit with PubMed Central in a way that is consistent with copyright law. I call it a “NIH seal of approval” list!

Question 2: One idea is to develop a standard communication process with research offices in institutions to facilitate compliance. One part of that might be an automatic notification system when an institution’s article has been deposited into PubMed Central. I also wonder if there could be some automatic means to create batch deposits/uploads between PubMed Central and institutional repositories. Creating an automated system would save time for all parties.

Finally, it would be helpful if the NIH grant application form/e-submission included a field requiring citation to all previously required PubMed Central deposits as part of ensuring that an application was complete.

Question 3: It would be very helpful if this site could incorporate an RSS feed or an automatic email notification when new information is added to the page.

Question 4: I am a library faculty member at California State University, East Bay, one of many institutions that benefit from the new NIH policy. Thank you for the opportunity to weigh in on this subject.

I currently work with our Chemistry faculty in particular. This faculty actively engages in research, securing grants for their work, and contributing new knowledge to their disciplines. This policy now provides unprecedented access to published research and as time passes, that access will grow exponentially. As our campus is not rich, this will foster and support the work in which they engage. It will improve not only their research, but their teaching. Our students participate in faculty research projects as well as engaging in their own research projects. In addition, the availability of information formerly difficult to access will allow faculty to bring new ideas and research successes into their classrooms. This is our core mission and the NIH policy contributes directly to that mission.

As the person responsible for “spreading the word” on campus, I have provided our faculty with a campus web site that includes instructions on how to comply and how to help publishers of their articles meet the NIH requirements. This is available at http://www.library.csueastbay.edu/copyright/nih.htm, which is our current site, but is also available at http://libwiki.csueastbay.edu/wordpress/using-the-libraries/services/copyright/nih-requirements/, which will be the new site as of Summer quarter 2008. I have also worked closely with our Office of Research and Sponsored Programs, which has directed our current NIH grant holders to the page. Between us, we are working to ensure that these grantees and potential future grantees in our College of Science are aware of and informed about this program and related compliance issues. With this policy, we have a wonderful opportunity to collaborate across campus to ensure broad distribution and exposure for our institution research findings.

We want and need this program to work.

I am aware that there is opposition to this policy on the grounds that this may have a detrimental financial effect on publishers of science journals; however, that would only happen if libraries canceled subscriptions in a wholesale manner. As a library faculty member and practicing librarian, I do not foresee this. There are safeguards in the form of the embargo period and the demands that the requirements for author manuscripts require.

There are also concerns that the policy conflicts with current copyright law; however, I have worked with copyright for decades and I fail to see how this is the case. It is reasonable for the public to expect the availability of information that they sponsor through their governmental taxes.

I have made several suggestions in the question boxes above. In the meantime, as we go through this shakedown and adjustment phase for the new policy, I wish to re-iterate my appreciation for this policy and the gifts it is providing to our faculty and students. It is an important step forward in the sharing of new knowledge.

Question 1: Yes, the IEEE believes that the NIH should seriously consider enlisting experienced scholarly publishers to help implement the Public Access Policy in a way that will provide maximum benefit to the public. For instance, the NIH could offer the metadata and references of published articles from NIH-funded research and simply link from Pub Med Central to the publisher’s final version of the manuscript. The publisher could easily make the paper freely available from its own web site.

An alternative for NIH could be to adopt a SCOAP3 model (Sponsoring Consortium for Open Access Publishing in Particle Physics) for supporting NIH-funded research. Like SCOAP3, NIH would reimburse publishers for the cost of making NIH-funded research publicly available, in lieu of an author payment. IEEE recently expressed an interest in working with CERN and SCOAP3 to experiment in this area.

Another alternative would be to have the NIH contract with one or more publisher to host all published NIH-funded research on existing digital archives such as the IEEE’s Xplore platform. Such an arrangement would give readers access to existing specialized search tools (like Scitopia) as well as to cross linking with other STM literature.

We urge the NIH to consider these alternatives to ensure that it will not unnecessarily waste taxpayer funds building an article repository and web delivery system that duplicates what already exists in the operations of scholarly publishers.

Question 2: There are two compliance issues that will need to be monitored: 1) whether the article is submitted at all, and 2) whether the version posted on the NIH’s Pub Med Central is an accurate representation of the published article.

The IEEE sees significant complications in this second issue that will make ensuring compliance difficult. Although the NIH requires that NIH-funded investigators submit an electronic version of the author’s final manuscript resulting from the peer review process, this nuance is likely to cause a difference in the version posted to PMC and the final publisher’s version of the article. In addition, it is our experience that it is challenging to capture the attention of the author to review the copyedited version of the manuscript before it is finally published. Thus, the NIH’s practice of converting the article to XML and then requiring authors to again review the NIH version, after it’s been converted to XML, is redundant and will ultimately cause even a greater difference between the PMC and publisher’s own version of the manuscript. Experienced publishers are aware that conversion to XML needs to be done very carefully in order to avoid introducing errors. How will NIH monitor conversions that it undertakes, and how will it ensure that only errors introduced in the XML conversion process are corrected, while maintaining the integrity of the content itself?

If PMC linked metadata, in lieu of the full manuscript, to the publisher’s web site (for the final version of the manuscript), it will have accomplished its goal of ensuring compliance and meeting the directive to implement the public access policy in a manner consistent with copyright law. Moreover, it will ensure that the production qualities of the manuscripts to which it provides public access are as high as possible.

Question 3: The posted information is fairly massive, and it is not easy to find answers to the questions that might occur to an author or grantee. One question that comes to mind is: Does NIH have a procedure in place to notify all those responsible that the required submission has been successfully completed?

Question 4: We hope you will review IEEE’s set of “Principles of Scholarly Publishing” at http://www.ieee.org/web/publications/rights/PublishingPrinciples.html. We believe that these principles are important in order to carry out our publishing mission successfully. The IEEE is committed to providing access to scholarly and professional publications in a convenient, timely, and affordable manner. We are supportive of alternative publishing models, like public access, as long as there is a business model to sustain these activities.

Among the publishing principles IEEE has adopted are:

• Society benefits from an objective and intellectually free scholarly publishing environment that is unfettered by censorship or bias based on personal, commercial, or government agenda. • In order to perpetuate itself, scholarly publishing requires financial support from self-sustaining business models. • Copyright and intellectual property rights of authors and publishers must be protected in any publishing activity, including those that involve government-mandated policies on access to government sponsored research.

We urge NIH to consider using IEEE’s well-established and proven online content delivery platform, IEEE Xplore, to serve the needs of the NIH and the public instead of allocating potential grant funds to duplicate publishers’ activities.

05/27/2008 at 09:31:52 AM

Frank

Martin

Ph.D.

American Physiological Society

Bethesda

MD

USA

NIH-funded Investigator

Question 1: The RFI asks for recommendations for alternative implementation approaches. We continue to believe that a partnership between NIH and journal publishers would better achieve NIH’s goals while also addressing our community’s concerns about the policy as outlined above. Instead of NIH undertaking a whole new publishing venture that involves formatting and publishing unfinished manuscripts of authors, NIH should use existing links from NIH’s highly respected PubMed to journals’ websites for reader access to final, published articles. To address NIH’s desire to create an archive of manuscripts reporting NIH-funded research, journals would provide to NIH immediate access to journal content for internal use. This mechanism has several advantages to the current implementation plan. It would relieve the administrative burden on NIH-funded scientists because they would not have to take any additional steps to comply. They would simply continue submitting manuscripts to journals, as they always have. The integrity of the scientific literature would be ensured because only the final, published version of the article would be publicly available and archived by NIH. Articles would be available at significantly lower cost since publishers are already publishing, editing, and posting articles at no additional charge to the public. The database of articles would be more comprehensive and accurate for NIH portfolio analysis and strategic planning. This proposal was put forward by 56 organizations and publishers on October 15, 2005, and we urge NIH to reconsider it. This proposal would fulfill the public access policy as enacted by the Consolidated Appropriations Act of 2008 and would also specifically address copyright law concerns expressed by Congress.

Question 4: It is critically important for NIH to comply with the policy especially if it expects its investigator community to do the same. Consequently, NIH must not accept articles that are not within the time frame of the policy. Specifically, NIH should not accept articles published prior to May 2, 2005 or April 7, 2008, which ever date NIH decides is the designated start date.

NIH should also provide assistance to investigators by working with publishers to create a database of journal embargo dates. How can an investigator publishing in multiple journals remember the policies of all of them. Just as one can search by journal in PubMed, the manuscript submission site for PMC should include a journal search capacity that would allow for the release period to be populated by default from the NIH created database.

The release date of 12 months should be defined as 12 months after final publication, not 12 months after the journal's posting of the accepted manuscript on a journal website two to three months in advance of final publication.

It is also strongly recommended that NIH only accept researh related mansucripts and/or papers into PMC, not the review articles, editorials, and commentaries commissioned by editors to scientific journals. In advance of the voluntary plan, NIH and Dr. Zerhouni encouraged editors to enhance the value of their subscription based journals by inviting reviews, editorials and commentaries. To now require that such peer-reviewed material be depositied in PMC is inappropriate and not reflective of the earlier policy.

05/27/2008 at 09:02:42 AM

Eaton

Nancy

MLS

Penn State University

University Park

PA

USA

Representative NIH Funding Recipient Organization

Question 1: Penn State University appreciates the opportunity to again submit comments expressing support for the NIH Public Access Policy. We believe the policy provides an unprecedented opportunity to create a publically accessible archive of NIH supported research that has the potential to accelerate the pace of research and discovery, promote innovation and serve patient needs and the public good. The following comments supplement earlier remarks made during the original request for information period (March 2008). Since that time the University Libraries, the Senior VP for Research and University Legal Counsel have been working on implementation of the Policy. We have: • Disseminated information explaining the policy to our NIH Principle Investigators and research administrators across all Penn State Campuses. • Developed a comprehensive website addressing issues related to compliance with the policy, including information on copyright, links to NIH Policy FAQ’s, and PubMed Central. • Developed a copyright addendum, using the language suggested by NIH, which has been vetted and approved by University Legal Counsel for use with publisher agreements. • Created a practical “How to Submit Your Manuscript to PubMed Central” training class with step-by-step instructions for use across the Penn State campuses. • Periodically send out targeted e-mails to NIH funded researchers with updated information in order to keep them informed.

Question 2: While Penn State University recognizes the concerns expressed by the publishing industry and others we feel these are largely unfounded. We reiterate the following: • Encourage publishers to reduce barriers to submission and work with authors to ensure compliance with both the policy and copyright law. • The NIH Policy affects only articles supported by NIH funding. This is a subset of all the articles published and affects only certain articles across a large cross-section of journals. University Libraries has no plans to cancel journals as a direct result of the policy. In addition both the 12 month embargo and the requirement for the author’s final peer-reviewed manuscript prevent this. • Retain a list of publishers whose publishing agreements take into consideration the need for depositing with PubMed Central consistent with copyright law. Continue to update the list of publishers who directly submit articles to PMC. • Consider developing a process for communicating with campus offices of research in order to ensure compliance. • Consider developing an automated approach to coordinating deposit between PMC and institutional repositories. • Consider some type of automated notification that would be sent to the institution/campus office for research when articles are submitted. • Provide a mechanism to construct a simple PubMed search that would provide an exhaustive list of papers affiliated with an institution and funded by NIH.

Question 3: We find the updated FAQ’s very helpful. Providing current information on the NIH Public Access site contributes to our ability to keep our faculty and researches informed.

Question 4: Penn State University welcomes this opportunity to express our appreciation and support for the NIH Public Access Policy and its goal of public access to the published results of NIH-funded research. We are confident that in working together we can positively impact the scholarly communication process in ways that benefit society as a whole.

Question 1: I very much support the NIH Public Access Policy and believe that it is critical to libraries and to the scholars they serve. I believe it is implementable in its present form.

Question 2: I believe that the plans for implementation that universities are developing will assure good compliance. Aside from plans NIH already has determined, I have no further monitoring usggestions.

Question 3: I have sufficient information.

Question 4: Just to reiterate the importance of this policy and all the work we can do to assure its robust implementation.

05/23/2008 at 04:02:13 PM

Folsom

Aaron

MD

University of Minnesota

Minneapolis

MN

USA

NIH-funded Investigator

Question 4: I have two comments:

1. This policy is an extreme waste of time and should be rescinded, or journals, not PIs, should be required to take care of it. Why is it crucial that articles be made public a few months before publication, when people can wait and get the publication in other ways? How much money is this costing, and for what gain? It's a prime example of wasteful governmental bureaucracy.

2. One problem with implementation is that PIs are responsible for ensuring articles are submitted and cited, but papers are written by authors that may not include the PI. So, there is a disconnect between who knows about the acceptance for publication and who is held responsible.

Question 3: The posting itself is a minor nuisance. But including PMC ID numbers in bibliographies is a real problem, especially if we need them for all published papers (not just our own). This is because companies such as EndNote and RefManager (and they are nearly all owned by Thompson now) do not correctly retrieve or cite PMC ID numbers. It would be very helpful if NIH or HHS leaned on Thompson to fix this problem and distribute an "NIH Style" file.

Question 4: no

05/23/2008 at 02:43:02 PM

Andreadis

Debra

Denison University

Granville

OH

USA

Representative NIH Funding Recipient Organization

Question 1: I believe that the embargo period should be shortened to 6 months given the speed with which publishing in the sciences occurs. I do not believe that this will threaten the publishers livelihood, as our researchers will still need active subscriptions to current publications to further their research.

Question 2: There should be an automated way for grant offices in universities to be advised of the posting of their researchers' papers in PubMed Central. I also think that grant proposals from those who have previously received grants should require a section for the links to previously published work within PubMed Central.

Question 3: I think you have done a good job with the information on this website. I currently do not have any further suggestions in that area.

Question 4: I want to commend the NIH on this initiative. I support it wholeheartedly and look forward to its continuance.

05/22/2008 at 02:15:09 PM

Roberts

Richard

Ph.D.

New England Biolabs

Ipswich

MA

USA

Other

Question 1: 12 months is too long to wait. This should be reduced to 6 months as soon as possible and then to 3 months and finally to 0. NIH should engage the publishers so that it is they, and not the PI, who is responsible for deposition into PubMed Central. Funds must be mae available to NIH grantees specifically to cover the costs of this. NIH has sufficient clout that it shoukld be able to negotiate reasonable costs with the publishers to ensure that the published manuscripts can be deposited in PubMed Central. Deposition on a publisher's web site is not satisfactory since we need the literature in a single location where it can be searched or downloaded for local searching. This literature is our heritage and it belongs to the scientists who generated it and the funding agencies that paid for it. There can be no excuse for we scientists (I am a Nobel Laureate and work as Chief Scientific Officer for a small company. I am also chief US editor of an open access journal, Nucleic Acids Research) to have to repay the publishers to read our own work.

Question 2: NIH must talk to the publishers so that they assist in this endeavour. The sooner the publishers are convinced that this move to open access is inevitable then the sooner they will be prepared to help make it happen. This will require talk and good faith negotiations. Ultimately, it is funding agencies like the NIH that has the clout to make it work. We sacientists can only help by publishing in compliant joournals, refereeing for compliant journals and serving as editors for them. This does give us some bargaining chips, but far less than the NIH and the other finding agencies.

Question 3: Some stronger words about how best to convince our Universities and employers to deal with the publishers over copyright to the publishers. All they need is a license to publish.

Question 4: This is long overdue and very much a step in the right direction. When the literature is fully available on line for free that will do more for science than almost any other initiative I can think of.

05/22/2008 at 01:31:10 PM

Canizares

Claude

Ph.D.

Massachusetts Institute of Technology (MIT)

Cambridge

MA

USA

Representative NIH Funding Recipient Organization

Question 1: MIT is pleased to comment again in support of the 2008 NIH Public Access Policy. MIT’s mission to “generate, disseminate, and preserve knowledge” is reflected in and supported by this policy, which will advance science and make publicly funded research more widely accessible, leading to benefits for taxpayers and for society. Since our comments in March, a group of staff from our Office of Sponsored Programs, Office of General Counsel, the Libraries, and the Vice President for Research, in conjunction with faculty, have been working on several aspects of implementation. We have:

• Announced and explained the policy to our NIH Principle Investigators and research administrators campus-wide; • Prepared two web pages for authors: an overview, and a step-by-step guide for compliance; • Created a submission letter and revised MIT amendment to publisher agreements for authors’ use; • Presented to research administrators about the policy and compliance with it; • Modified our internal grant application process to flag the new policy; • Worked with the NIH on search strategies to properly identify MIT-authored works via PubMed and PubMed Central; • Consulted with colleagues and NIH on possible third-party submission support that might be offered to MIT authors; • Investigated key publisher policies for NIH-funded research and documented them for MIT authors; • Communicated about the policy with many publishers, and received responses from some of them. We have been working with individual authors on preparing appropriate publisher agreement amendments so that they can comply with the new policy without coming into conflict with any publisher copyright policy. This activity forms part of our overall author support program that assists MIT authors in considering how to manage the rights to their work.

Question 2: While MIT applauds this new Public Access Policy, our recent implementation efforts have suggested several approaches that would be useful moving forward: • To the extent that publishers can be encouraged to reduce or eliminate delays in public access from the current 12-month maximum, MIT’s and society’s goals will be more fully served, without any impact on library subscriptions. (The NIH policy, which affects only some articles in some journals, will not alter the purchase of subscriptions at MIT.) • The development of inter-institutional partnerships could simultaneously support authors, universities, and the overall goals of the policy: o Collaboration between NIH and universities to develop methods for exchanging data and papers between PMC and institutional repositories could maximize efficiencies in making research openly available. o Collaborations between publishers, universities, and NIH to develop institutional policies and systems would reduce the burden on individual authors in complying with the policy. During this phase, while compliance with the policy lies largely in the hands of individual authors and relies on adequate rights retention when publishing, we need the full cooperation of publishers, particularly in smoothly accepting amendments to standard publisher agreements. • More immediate, smaller changes from NIH would smooth efforts to comply with the policy, including: o Notifying the grantee when a relevant paper is submitted to PubMed Central (whether by publisher, author, or third party). o Altering workflows such that it would be possible to construct a simple PubMed search that consistently offers an exhaustive list of papers affiliated with an institution and funded by NIH. o Indexing all NIH funded papers, not just those published in life sciences journals, in PubMed.

Question 3:

Question 4: We welcome the opportunity to support this policy and its goal of more open access to research. We are optimistic that in working with publishers, NIH, and others, we can together refashion the scholarly communication process in ways that harness technology’s potential to benefit society through quick, open sharing of scientific research.

Question 1: 1. The inclusion of new language extending the policy to review articles is of serious concern for the following reasons: (1) the original work cited in the article, if funded by NIH, would already have been disclosed and made available; (2) review articles are not original research that could be tied to a specific NIH grant; and, (3) journals and their subscribers place a high value on review articles, as they represent unique content and include added analysis. Loss of such articles as a benefit to paid subscribers has significant financial implications.

2. In many cases, deposition of the manuscript is duplicative since they are available free of charge on the publisher’s site after 12 months. NIH should consider the costs that could be saved by simply linking to the publisher's sites and not duplicating existing services already provided by publishers.

Question 4: The American Society for Nutrition is the professional scientific society dedicated to bringing together the world's top researchers, clinical nutritionists and industry to advance our knowledge and application of nutrition. Our focus ranges from the most critical details of research and application to the broadest applications in society, in the United States and around the world. ASN publishes The American Journal of Clinical Nutrition (AJCN) and The Journal of Nutrition (JN), the two leading, peer-reviewed scientific journals in the areas of nutrition science and dietetics. ASN appreciates this opportunity to provide comment on the implementation of the NIH Public Access Policy.

ASN supports the principle of public access to science and voluntarily has taken the following significant steps to accomplish this: • The abstracts of ASN journals are indexed in MedLine, which is accessible over the Internet from NIH’s PubMed website. • In 2000, ASN began offering free public access to articles 12 months after publication. • By 2006, the ASN put its entire journal collection, including over 110 years of archival content, online through Stanford University’s High Wire Press. Approximately 98% of online journal content is freely accessible to both subscribers and non-subscribers. • Since 1997, the Society has included free access to the online journal collection as a membership benefit.

ASN is part of a group of more than 59 scholarly publishers who jointly developed the D.C. Principles for Free Access to Science. The DC Principles include a commitment to these forms of free access: • Selected articles of public interest are free from the time of publication • The full text of articles is made freely available either immediately or within months of publication, depending upon what is economically feasible for the journal • Journals are freely available to scientists in many low-income nations • Relevant articles are freely available to individuals in case of compassionate need, i.e. to those seeking information about their own health or that of a family member • Public access to content is facilitated through indexing agreements with Internet search engines

ASN, like many non-profit scholarly publishers, reinvests the revenues from our journals in direct support of science through scientific meetings, research grants, educational outreach, advocacy, dissemination of information to the public, and improvements in scientific publishing. We believe our efforts constitute a sustainable approach to public access.

Notwithstanding our commitment to public access, ASN has serious concerns about the Public Access Policy currently being implemented by NIH. Our concerns are outlined below.

Administrative Burden The new policy places a significant administrative burden on authors, institutions and publishers. The low compliance with the voluntary policy (five percent of NIH funded articles in 2006 were deposited by the author) suggests this is the case. The fact that someone, be it the publisher or the scientist, must deposit the manuscript represents time and money. In many cases, deposition of the manuscript is duplicative since they are available free of charge on the publisher’s site after 12 months.

Review Articles The inclusion of new language extending the policy to review articles is of serious concern for the following reasons: (1) the original work cited in the article, if funded by NIH, would already have been disclosed and made available; (2) review articles are not original research that could be tied to a specific NIH grant; and, (3) journals and their subscribers place a high value on review articles, as they represent unique content and include added analysis. Loss of such articles as a benefit to paid subscribers has significant financial implications.

Copyright The inclusion of blanket requirements in grant contracts has the potential to deny authors and publishers the benefits of their copyrights, among those being the freedom to decide how and in what form their works may be distributed. Moreover, the policy as proposed by NIH may conflict with fundamental copyright principles and does not take into account the value added by publishers and editors. The NIH policy as currently proposed is not, in our opinion, consistent with the legislative mandate to implement said policy in a manner that is consistent with copyright.

Impact on not-for-profit publishers and scientific societies The NIH has not given appropriate consideration to the potential economic impacts of its proposal on publishers and the fundamental roles and services scientific societies provide to their membership and the scientific community at-large. These impacts may be especially severe for scholarly societies and not-for-profit publishers. NIH has stated in past notices that economic and business implications of any policy changes should be taken into account, and the danger that mandated access will interfere with the ability of journals to recover costs still exists. As ASN has implemented policies to improve public access to the research it publishes, the economic impact of these new policies was carefully considered. Certain considerations influence how soon free public access is economically feasible for a particular journal. These include revenue sources, production costs, utilization patterns, time needed for cost recovery, and frequency of publication. For example, it costs on average $3,500 to publish an article in AJCN or JN. NIH should have the same consideration for these factors. Ironically, it is possible that the NIH plan may have the greatest deleterious impact on not-for-profit publishers who already provide some form of free access.

Societies such as ASN derive the bulk of their revenue from journal operations. The membership of these societies – the very scientists who are also NIH-funded investigators – derive important benefits from membership in these societies. Such benefits include access to scientific meetings, organization and review of abstracts, provision of continuing medical education programs, mentorship programs for young scientists, and many more. It is clear that hobbling these societies is a major unintended consequence of the current proposal, and one that is not in the interests of researchers, NIH, or the American public.

Impact on researchers This proposal initially was intended to benefit researchers by broadening access to the scientific literature, but since the NIH policy would affect approximately 10 percent of that literature, it is not clear how helpful it would be. At the same time, journals that publish large amounts on NIH-funded research would suffer the greatest negative repercussions. If the NIH plan indeed undermines journal operations, ASN may have to scale back its publications programs or curtail the activities it supports to advance nutritional science. This could mean fewer opportunities for scientists to share research findings in a timely manner, expand collaborate projects, and train junior scientists. Should journals like ours seek to recover lost production costs by increasing fees charged to authors, research funding also would be affected. Regardless of where the money to pay fees originates—taken from existing grant funds or charged to the research institution or funding agency—the net result is less money for research.

Conclusion We respectfully request that NIH address the concerns as outlined above, and we urge you to fully involve publishers in the implementation of this policy. We look forward to continued dialogue on this important issue. If you have any questions, please contact John Courtney, ASN’s Executive Officer, at (301) 634-7050 or jcourtney@nutrition.org.

Question 1: No, I believe that NIH should mandate that publications funded by our tax dollars be available to everyone, not a select few. Lowering the embargo to 6 months would also allow information to be more quickly disseminated; patients, other researchers and physicians would be greatly helped by this. Publishers will not lose money by the authors providing critical information about current research; in fact, I believe that some journals may actually see their readership increase from the publicity brought by bloggers, news reporting agencies and others who read the articles and then discuss where the article and other information about this research can be found - which, of course, would be in the journal and its archives!

Question 2: Streamline the process and put strings on some of the funding - if needed, mandate within the grant that the researcher and the publisher not be allowed to publish the article until it is also available through the NIH, or some funding will be withheld.

Question 3: Continued publication and educational forums at conferences on the policy.

05/21/2008 at 05:43:29 PM

Tagler

John

Masters of Library & Information Science

Association of American Publishers, Professional & Scholarly Publishing Division

Question 1: Since PubMed Central will compete with publishers’ own websites as more PMC content overlaps with content on publishers’ sites, how will NIH maintain the primacy of the publishers’ websites and ensure that the manuscript on PMC does not displace or act as a substitute for the final published journal article (i.e., the authoritative version of record, which resides on a publisher’s site)? Will NIH work with publishers to ensure that readers know and are directed to where the final published versions can be obtained?

Question 2: Many publishers have already been providing free access to authors’ manuscripts or final published articles twelve months after publication or even sooner. NIH does not consider this access compliant with the NIH policy. Would NIH consider including author manuscripts only in its administrative database and archive, while providing public access via display only through publisher sites? If not, what is the rationale for maintaining an unedited manuscript for public consumption if the final, authoritative version has been made available for free access on the publisher’s site?

Question 3: What will NIH do in cases of noncompliance with its policy guidelines? What action will be taken when a grantee’s article is published, but NIH is not provided with the peer-reviewed manuscript? What actions will be taken against noncompliant grantees when they apply for future NIH grants?

Question 4: How does NIH anticipate securing and sustaining a source of funding to maintain the database of articles that will accumulate over time, including costs to migrate to new platforms? Under the new policy, US taxpayers will be funding public access to science to any person anywhere in the world with Internet access. Has the NIH considered the ramifications of providing such international access, and how this might affect national security or other US government trade regulations? Considering the far-reaching implications of the substantial change in the NIH public access policy, we urge HHS and NIH to address these and other issues raised during the review period before the NIH Public Access Policy implementation moves too far along without taking into consideration the points raised during the public review period. As we have repeatedly communicated, we would welcome the opportunity to work closely with NIH to resolve issues and concerns raised by the publishing community.

05/19/2008 at 12:33:39 PM

Reiter

Allan

PhD

US DoD, Defense Threat Reduction Agency

Ft. Belvoir

VA

USA

Other

Question 1: Make some arrangements to go back 5-10 years in the peer reviewed literature.

Question 2: A web site where apparent lapses can be reported for compliance and follow-up.

Question 3: None at this time, but I have found fedbizops (grants.gov) has a good notifier system for keeping my abreast of BAA's/RFI's, etc. from sister agencies.

Question 4: Highest of kudos for this first step! Long needed. It has been very difficult to review submitted research proposals against my agency's $millions in BAAs when our token library closed down five years ago. Even peer reviewed pubs from DoD laboratories often required a call to obtain. I hope all federal departments, including mine, would mandate the same requirement. We turn down many promising proposals for lack of "preliminary data". Citing a pub in a proposal does not work and we do not have the resources or time to track down the cited pubs during the vetting process. The new generation of doctoral scientists that we hire to manage R&D programs have no way to keep up with the literature without access to the peer reviewed literature. The cost of this new policy will more that pay its way by leading to better awards in the future.

05/18/2008 at 06:12:43 PM

Fister

Barbara

MLIS, MA

Gustavus Adolphus College

St. Peter

MN

USA

Other Member of the Public

Question 1: I don't have particular concerns about the implementation; I just am happy that the NIH is taking this leadership role. As a librarian at a small college, our ability to support the work of young people getting started in the sciences and to support the work of their faculty mentors has been limited by a budget that can't sustain expensive STM journals. It makes sense for publicly-funded research results to be available for all, and it's a great help to us.

Question 2: I hope that the researchers involved will understand that their research will reach a wider audience through this process. That has both personal and public benefits.

Question 3: I think what you've made available already is quite helpful.

Question 4: Thank you for taking these steps. It's much appreciated.

05/18/2008 at 08:44:09 AM

Eichenbaum

Howard

PhD

Boston University

Boston

MA

USA

NIH-funded Investigator

Question 1: I think the private publication system that has evolved for dissemination of research results works rather well, both for investigators and for the public. The information contained in publications is readily available already. I am highly concerned about the costs to NIH that will occur as a consequence of the new initiative. Journals will have to pass on their costs to investigators, who will request those costs in their grant applications. And I am concerned about the archiving organization and protections offered through the current system.

05/17/2008 at 10:15:31 AM

Firnhaber

Gina

MSN, MLS

Laupus Library, East Carolina University

Greenville

NC

USA

Other

Question 1: I work as a librarian assisting researchers in medicine, nursing and various allied health professions perform literature searches to support and design their research. If studies are being supported with government (ie taxpayer) monies there should not be an entire year lapse before the results of these activities are available to other researchers. I support the rights of publishers to make money but placing an embargo on information that has been gained using government funding gives second place to the people who really funded its creation in the first place. Perhaps a simple draft of study results should be publicly accessible initially and a cleaner, crafted paper required 1 year after publication. Researchers could access the early information and the public could be encouraged to focus on the more complete work.

Question 2: I think ensuring public access should be included as part of the grant process, not left up to individual researchers or organizations to police. If this requirement is written into the grant and followed up as such compliance will not be an issue.

Question 4: Much of medical research today is building upon other work and open access is essential for researchers. It also seems useless to fund research that does nothing but sit in a journal. In many cases the time between the discovery of information and implementation in the field is years, mostly from poor diffusion rates rather than access, but requiring research be avaible may help diminish this time lag, especially in research and research based practices.

05/16/2008 at 03:34:01 PM

Emmett

Ada

n/a

Lawrence

KS

USA

Other Member of the Public

Question 1: It is reasonable that the embargo period be shorted to 6 months. Publishers can easily still make their needed profits in the first 6 months (and beyond) since most researchers prefer/require the most recent research. The shorter embargo period however gives the general public (who has funded the research through tax dollars at both the state and federal level-- funding the salaries of researchers/faculty at state universities and colleges and through federal grants). It is time that a balance be struck, where there has thus far been none, between the need for commercial and non-profit publishers to earn at least a modest profit for their value-added work and the (thus far ignored) need for the public to have rights to the social and public good it funds.

Question 2: In addition to the methods currently in place perhaps the institution/agency that monitors the grant for the individual researcher, should supply documentation of compliance.

Question 4: Let me add that although it is more work for the researcher to submit their final manuscript (one more step in a bureaucratic maze of steps)—it is time that scholars/researchers/academics accept the fact that they play a pivotal role in the cycle of knowledge production and consumption. As scholars they must have access to the products of other's research and they must make their results known. The products of scholarship are a public good. Even if they are researchers for the sheer joy of research (with no sense of owing something back to humanity, the Knowledge Commons, society,—whatever one chooses to call it) they must realize that the current system is not sustainable as it is and that the entire world is waiting for a variety of shifts to take place and establish a just balance between the needs of the public (reading, researching and tax-paying public) and the needs of Big Business. The NIH requirement is a first important step.

05/16/2008 at 02:50:17 PM

Lewis

Margaret

University of Illinois

Champaign

Ill.

USA

Other Member of the Public

Question 1: Not at this time. I am new to this issue. I strongly support wide access to all publicly funded research. As a library employee I know that decisions to cut journal subscriptions are made daily because of the cost and libraries limited funding.

Question 2: No

Question 3: More information directed to the general public. This is an issue everyone should be interested in.

Question 4: Sounds like a reasonable plan.

05/15/2008 at 10:25:28 AM

Mercer

Holly

MLIS

University of Kansas

Lawrence

KS

USA

Representative NIH Funding Recipient Organization

Question 1: Regarding possible changes to the revised NIH Public Access Policy, the University of Kansas encourages NIH to reconsider the current embargo period of 12 months. An embargo period of 6 months or less is appropriate and will advance science through the sharing of new knowledge. Research libraries will not cancel needed biomedical journal subscriptions if a 6 month embargo is implemented. A 6 month embargo constitutes too long a delay for access to needed research information. Moreover, there remains a significant amount of needed biomedical information not covered by the revised NIH Public Access Policy.

Question 2: It would be helpful if NIH posted and routinely updated a list of publishers whose author agreements permit authors/institutions to comply with the NIH Public Access Policy. It would be helpful if NIH could automatically notify the Office of Research and Graduate Studies or the KU Libraries when an article has been deposited in PubMed Central.

It would be helpful if NIH would work with academic institutions on coordinated manuscript deposit between PubMed Central and institutional repositories.

Question 4: These comments are submitted on behalf of the University of Kansas. We commend NIH for soliciting comments while moving ahead in a timely manner with this critically important congressionally approved policy. The University of Kansas supports the revised NIH Policy because it supports the University’s mission encompassing teaching, research and service as well as an international dimension and humanitarian values. Public support for science is enhanced when the public can see the benefits from our investments in scientific research. Scientific research is advanced with the wider dissemination of new knowledge. The Office of Research and Graduate Studies and the KU Libraries have been actively engaged in assisting NIH funded researchers in complying with the revised policy. We have held information meetings, and created a web page to assist researchers and grant administrators with compliance. Our institution has paid particular attention to copyright management and access issues. Helping authors make informed decisions so that they exercise their rights and interests in the ownership and use of copyrighted works and in a manner that promotes the greatest possible scholarly and public use of their work, is an important focus for the University of Kansas.

05/15/2008 at 05:17:53 AM

Shields

Peter

MD

Georgeown University

Washington

DC

United States

NIH-funded Investigator

Question 1: Do not place pre-prints in the depository, but only the final publication. The way it is now, there will be multiple versions of a manuscript in the public domain. The one you require may have errors that do not get corrected until the final proof.

Question 4: Do not place pre-prints in the depository, but only the final publication. The way it is now, there will be multiple versions of a manuscript in the public domain. The one you require may have errors that do not get corrected until the final proof.

05/14/2008 at 03:45:25 PM

Vinson

Daniel

MD

University of Missouri

Columbia

MO

USA

NIH-funded Investigator

Question 1: Require only the abstract. In CRISP, link all publications to the grant that funded the work.

Question 4: Some journals are proposing to charge a few thousand dollars to publish an article with open access. Because many papers are published after grant funding ends, this will create a burden for investigators and/or their institutions. It will likely cause shifts in which journals we submit papers to. Thanks for reading. Dan Vinson

05/13/2008 at 03:39:18 PM

Koopman

Ann

M.A.

Thomas Jefferson University

Philadelphia

PA

USA

Other

Question 1: Speaking as a librarian and manager of the University's institutional repository, I strongly encourage the NIH to reduce the permitted publisher embargo period to 6 months, instead of 12. Existing web-based support information and third-party deposit options are extremely helpful. Our library has created a brochure and webpage to educate our faculty. We strongly support the NIH Public Access Policy, and are providing staff assistance (for copyright education, deposit, and PMCID searching) to assure its success with our faculty.

Question 2: I am concerned that some researchers will regard the policy as just so much busy work, and will ignore it or seek ways to avoid compliance. Early feedback from our research staff includes a fair amount of irritation at the additional requirement.

05/13/2008 at 02:39:02 PM

Teschner

Craig

MBA, BSMT

Genetic Therapeutics International

South Grafton

MA

USA

Patient or Representative of a Public Health Advocacy Organization

Question 1: Recommedations would include requiring grantees to publish results of their investigations in the public access forum: The Public Access Policy which has access to published results of NIH/NCI funded research and clinical trials in through the PubMedCentral.

05/13/2008 at 09:00:24 AM

Miller

Jonathan

MLS

Rollins College

Winter Park

Florida

USA

Other

Question 1: Just make it as easy as possible for authors to submit their manuscripts. In my experience with other institutional repositories , users need a lot of support in successfully submitting documents. Make it flexible and simple and you will avoid non-compliance.

Question 2: See my answer to question 1.

Question 3: None, i think you have done a fine job so far. Keep it up!

Question 4: As a library director of a small private liberal arts college with good, but limited, library resources, open access initiatives like yours are a very helpful way of enabling our students and faculty to get access to a wide range of high quality research materials. Previously, they would have had to travel to a major research library or rely on interlibrary loan for in depth research in a wide range of subjects. With access to PubMed and the fulltext of these NIH funded articles our studetns are far better prepared for graduate school and professional careers. In the long term this should help with the shortage of health care professional in Florida.

05/12/2008 at 03:50:06 PM

Alley

Keith

Ph.D.

University of California, Merced

Merced

California

USA

Representative NIH Funding Recipient Organization

Question 4: As the first American research university of the Twenty-First Century, the University of California, Merced is committed to the kind of new thinking and innovation that informs the NIH Public Access Policy. UC Merced is deeply appreciative of the leadership and foresight shown by the NIH in implementing this policy.

The UC Merced Library provides access to some 20,000 full-text journals but carries no print-format journals. We believe it is only a matter of time until this strategy becomes the norm rather than the exception. Clearly, the NIH Public Access Policy enhances this emerging way of managing a research-library journal collection.

Even more important is the long-term impact the NIH Public Access Policy, in conjunction with similar policies, will have on the future UC Merced School of Medicine. Designed to bring medical education and improved medical care to California’s Central Valley, our state’s most medically underserved region, the UC Merced School of Medicine will follow a distributed model in which students and faculty are spread up and down the Central Valley rather than being clustered around a single teaching hospital. Unimpeded access to online medical research of the sort made possible by the NIH Public Access Policy will be vital under such an educational model, with the ultimate beneficiaries being the residents of California’s Central Valley.

The University of California, Merced commends the NIH for moving access to medical research into the Twenty-First Century and encourages NIH to stand by, and eventually expand, its Public Access Policy.

05/12/2008 at 01:33:59 PM

Schwartz

Elliot

Committee for Economic Development

Washington

DC

United States

Other Member of the Public

Question 1: The Committee for Economic Development is a 65-year old, independent, nonpartisan organization of business and education leaders dedicated to research and outreach to the public and private sectors on major economic and social issues. I am writing with regard to The National Institutes of Health (NIH) Public Access Policy (NOT-OD-05-022).

CED most recently issued a report entitled Harnessing Openness to Transform American Health Care (February 2008). The report (available at http://www.ced.org/docs/report/report_healthcare2007dcc.pdf) made the following recommendations regarding openness, publishing and disclosure of research results: • The explicit policy of the federal government should be to promote the broadest possible access to research results in the healthcare arena, particularly government-supported research. • Those federal agencies supporting research should positively respond to requests for funding to pay for publication/disclosure of sponsored research. • In evaluating applicants for research funding, federal agencies supporting research should recognize the scientific value of database science and scholarly work that may be validated by means other than traditional scholarly publication. • Federal agencies supporting research should require that sponsored researchers disclose potential conflicts of interest in any publications/disclosure of the sponsored research. • Federal agencies supporting research should target efforts to reduce the interval between publication/disclosure of research and its implementation in accepted treatment regimes.

The report took a favorable view of the National Institutes of Health’s leadership on these issues critical to accelerating the pace of research, promoting new discoveries and stimulating innovation.

CED, consistent with these principles, supports the NIH public access policy as articulated. If any changes were to be made, CED would favor a shorter embargo.

05/12/2008 at 12:55:37 PM

Williams, II.

James

MS

University of Colorado - Boulder

Boulder

CO

USA

Representative NIH Funding Recipient Organization

Question 4: Thanks to NIH for the opportunity to comment. Th policy sustains the gift culture among faculty while expanding access to NIH-funded research and its use. The policy will accelerate research and discovery on this campus while generally supporting the development of new knowledge within and beyond the academy. We have already devoted considerable institutional time to the development of protocols that will ensure compliance with the current implementation. And, in the meantime, the library will not cancel journals as a result of this policy; we have developed a faculty rights website that points to the new policy; and I encourage NIH to develop automatic notification and submittal procedures and protocols in order to streamline and leverage the ingest of papers to PMC. Lastly, please continue to reconsider shortening the embargo period to 6 months. I fully support the policy and its implementation. Thanks again for the opportunity to comment.

05/12/2008 at 10:50:53 AM

Van Orsdel

Lee

MLS

Grand Valley State University

Grand Rapids

MI

USA

Other

Question 1: Cut the embargo to 6 months. Timing is everything in health and related research, and 12 months is too long to let new information remain inaccessible for those who need it and cannot afford to purchase it. Particulary when we, the taxpayers, have already paid for it once (salaries and laboratories of researchers in state-supported schools) or twice (subscriptions paid by the same institutions). Publishers worry that this policy will threaten their livelihoods, but universities are not going to cancel critical research journals with a 6 month embargo. Faculty would not stand for it.

Question 2: Universities are prepared to take a role in facilitating compliance with NIH, and a link between the grantees' institutional repository and the NIH would facilitate both monitoring for compliance and the uploading of documents into PMC. Most universities have an office of research, even if the institution is not rated as a research institution. These university officers of research would be the logical contact to work with the NIH in an ongoing, routine manner.

Question 3: Health-related research is exploding in western Michigan,with a new medical school, several new hospitals, and expanding health-related research institutions expanding or building new facilities. My university is the major regional hub for educating students for health related fields--nursing, physical therapy, physician's assistants, occupational therapy, lab techs, etc. We are well-funded but can't begin to purchase all of the relevant journals to those fields. Information fuels education and invention. The more freely it is shared, the faster society feels the benefit. Subscriptions put barriers between practitioners and the information they need to treat patients. Their patients have already paid taxes to generate this information--having timely access to it may save their life or that of a child or parent. It is unconscionable not to make the information free and open to everyone who can benefit from it.

Question 4: The NIH Public Access Policy if one of the best examples in my lifetime (61 years) of the government truly deciding for the people. I'm so proud of all that it represents, both theoretically and practically. It takes courage to face the opposition from the commercial sector, who fear the demise of their industry as a result. My colleagues and I, in academic institutions of all sizes, believe their fears are overblown. You have done the right thing, and that pretty much says it all.

05/12/2008 at 08:45:36 AM

Krementsov

Nikolai

PhD

University of Toronto

Toronto

Ontario

Canada

NIH-funded Investigator

Question 4: Does NIH public Access Policy apply to a book-length manuscript/monograph?

05/08/2008 at 04:21:49 PM

Newman

Katie

Ph D

University of Illinois

Urbana

IL

USA

Representative NIH Funding Recipient Organization

Question 3: I think it would be helpful if the NIH site provided more information for scholars on how they can assure themselves that they have the RIGHT to put their manuscripts in PMC. For so long they have been blithely signing the publishers copyright agreement forms -- frequently giving away ALL their rights, that I feel this is an area with great opportunity for education. In ALA jargon, this would be "Author Rights" education.

I appreciate the verbiage that NIH has provided. But they could also point folks to the Sherpa/Romeo site <http://www.sherpa.ac.uk/romeo.php>, where authors can see if their publisher, de facto, is "NIH compliant".

Question 4: The University of Illinois has put up a support site for our researchers. But as the NIHMS submission process is really quite straightforward, I feel that the real added value we are providing our NIH grantees is the guidance concerning their copyrights. See: http://uiuc.libguides.com/content.php?pid=8114

Additionally, we are offering to do third-party submissions for our authors. And we are using the NIH Public Access mandate conversation as an opening for suggesting that our researchers also put their manuscripts in our institutional repository, IDEALS.

Question 1: The Federation of American Societies for Experimental Biology (FASEB) is a coalition of 21 scientific societies, representing more than 80,000 investigators. Our mission is to enhance the ability of scientists to improve, through their research, the health, well-being and productivity of all people.

FASEB and member societies collectively publish approximately 50 journals using a range of publishing models. They will be affected differently by the policy, and some of them will raise additional issues. All believe that the NIH public access policy does not represent the best method of achieving NIH’s goals of public access, portfolio management, and archiving of manuscripts reporting on NIH-funded research. In addition; we believe the policy will duplicate private publishers’ services using public funds, undermine the integrity of the scientific literature, and impose an unnecessary burden on investigators and institutions.

The NIH approach is inferior to innovations that publishers currently offer and continue to invest in improving. Most of our member society journals make their entire content available freely after 12 months or sooner, offer content at low subscription and pay-per-article fees, and provide enhanced functionality including integrated links to research databases. FASEB is proud that its member societies are in the forefront of electronic publishing and archiving. We believe that NIH should work collaboratively with publishers to encourage and promote these efforts, not attempt to duplicate or compete with them.

The RFI asks for recommendations for alternative implementation approaches. We continue to believe that a partnership between NIH and journal publishers would better achieve NIH’s goals while also addressing our community’s concerns about the policy as outlined above. Instead of NIH undertaking a whole new publishing venture that involves formatting and publishing unfinished manuscripts of authors, NIH should use existing links from NIH’s highly respected PubMed to journals’ websites for reader access to final, published articles. To address NIH’s desire to create an archive of manuscripts reporting NIH-funded research, journals would provide to NIH immediate access to journal content for internal use. This mechanism has several advantages to the current implementation plan. It would relieve the administrative burden on NIH-funded scientists because they would not have to take any additional steps to comply. They would simply continue submitting manuscripts to journals, as they always have. The integrity of the scientific literature would be ensured because only the final, published version of the article would be publicly available and archived by NIH. Articles would be available at significantly lower cost since publishers are already publishing, editing, and posting articles at no additional charge to the public. The database of articles would be more comprehensive and accurate for NIH portfolio analysis and strategic planning. This proposal was put forward by 56 organizations and publishers on October 15, 2005, and we urge NIH to reconsider it. This proposal would fulfill the public access policy as enacted by the Consolidated Appropriations Act of 2008 and would also specifically address copyright law concerns expressed by Congress.

It is FASEB’s recommendation that NIH efforts should focus on ways to work with publishers to achieve common goals, and we stand ready to work with NIH on this effort.

Question 4: The NIH policy may cause confusion about the article of record. Changes made by NIH that will result in variations from the original manuscript are of considerable concern. NIH needs to identify precisely how manuscripts will be linked to databases and other resources to ensure the integrity of the underlying work.

The revised mandatory public access policy now calls for submission of review articles. NIH previously encouraged publishers to add review articles to journals as a way to sustain the subscription base under the voluntary policy. Editors commission the review articles based on the scientific expertise of scientists; they are not based on specific research projects supported by NIH research grants. Furthermore, requiring that review articles be included will seriously undermine the many journals that publish review articles only.

The policy imposes an unnecessary administrative burden on researchers and their institutions. We question if this is the best use of investigators’ time and public funds. Given the magnitude of the policy, we remain concerned about the lack of rigorous analysis and public discussion of the cost involved. We request that NIH examine and publish the cost of this policy. We are concerned that the NIH publication policy will draw resources from other areas of critical research investment, particularly in this time of constrained budgets.

We are aware that there are calls for NIH to reduce the time of manuscript release to six months or less. This would seriously compromise the ability of most of the FASEB member society journals to provide quality peer review, editing, and publishing of NIH funded research results. We urge NIH to maintain the 12-month upper limit.

05/06/2008 at 12:15:37 PM

Hickey

Damon

PhD

Director of Libraries, The College of Wooster

Wooster

OH

USA

Representative NIH Funding Recipient Organization

Question 1: I am the Director of Libraries at the College of Wooster, a midwestern liberal-arts college that has long led among American colleges and universities in the percentage of its alumni who pursue graduate study in the sciences. Our record is due in part to our program of Independent Study, which requires all of our students to engage in original research in their major fields in their junior and senior years. Accessibility to published research, especially in the sciences, is therefore essential to the education of these students, many of whom will go on to be the next generation of American scientists and researchers.

I want to thank the NIH for their openness to comments from those of us who have a primary interest in the availability of scientific research. We support the Public Access Policy (NOT-OD-05-022) as currently articulated, because it will expand access by our faculty and students to NIH-funded research, accelerate research on our campus, contribute to our core mission as a research-based undergraduate institution, improve access for other institutions with fewer financial resources to important research, and ensure that citizens of this nation are able to get and use the results of the research their tax dollars have paid for.

Those who have opposed the legislation that led to this policy and who have demanded that an additional period for comments be opened have made false claims that the policy will result in the cancellation of journal subscriptions en masse. As the person responsible for purchasing these subscriptions, I can assure you that this is not the case. The fact that public access is not required for 6-12 months after publication means that we will continue to subscribe in order to obtain the results of research as soon as it is available. We know full well that crippling the scholarly publishing industry would not be in our interest, our faculty’s, or our students’.

05/05/2008 at 03:52:04 AM

Madhusoodanan

Ramakrishnan

PhD

NCCAM

Alleppey

Kerala

India

Representative NIH Funding Recipient Organization

Question 4: Some NIH portfolio journal's current trend have some uninterested policy to handling the NIH accepted author manuscripts.This may cause at least rather four month delay period in one journal submission to another and its respective, peer review . This may cause potential burden to comply NIH Public Access policy in some NIH supported investigator's manuscript publication at the proper time.I humbly request perusal NIH attention to this subject.

05/02/2008 at 05:53:11 PM

Boothby

Mark

M.D., Ph.D.

Vanderbilt University

Nashville

TN

USA

NIH-funded Investigator

Question 1: Yes. Many many many.

As implemented, it's horrific, arguably a violation of the law (poorly written in any case, and - even where NOT a direct violation of the law - ham-handed, counterproductive, and set to waste massive amounts of very scarce NIH $$$ to achieve the portion of the underlying objective that is laudable.

Rec #1 -- Work more constructively than you have with the many scientific societies whose journals provide open access to the information after a reasonable period (6-12 mo) post-publication. For instance, accept their offer of invisible autolinking from High-Wire (or their own WWW sites, autolinked already from NLM PubMed) to PMC (sneakily named PubMedCentral - distinct from PubMed). In addition, just program an autodownload conversion from PubMed entries (and their active journal links) to PMC, which don't become activated until investigator performs one simple click within 12 mo of publication date (or earlier, specifying a length of Embargo period).

Apart from those that already are on the NIH list of journals taking care of PMC transmission of papers on behalf of investigators, there remain two classes of journal: a. those that already make the information openly available to all with WWW access within 6 or 12 mo of publication, and therefore achieve your present objective, versus

b. those that do not, and may be almost impossible to drag into doing so because of their unique branding and (over)weighting in the cultural consciousness of medicine or science [i.e., NEJM, Nature and baby natures, Cell and baby cell press journals].

If you work constructively, instead of the current obstinate obstructionism, to bring journals of group a into the fold, the mass of high-value content will increase the pressure on the hold-outs.

2. Provide a clear path whereby scientists can use a PMID and embedded link {rather than a PMCID; heuristic point = PubMed and PubMedCentral are different units} in those instances where the open access need is already met as a matter of course. [Didn't Congress' appropriation include a specific point to the effect that "open access, as long as it does not violate copyright law"? So, NIH wants to implement things about like Mafiosi or the like (with the metaphorical gun to the head): don't publish in journals with concerns about PMC, too bad if your paper was under review at a journal with "non-compliant" copyright policy and got accepted April 10, and it's all your problem - we'll just make you certify that you were compliant.

Similarly, grant applications, progress reports, and other forms of reporting should allow ANY open access link that Congress, staff, NIH officials, other govt officials, reviewers, and the public can all use. [Is it not true that under current Federal Law, the simplest and lowest cost means of achieving compliance with the requirement incorporated into the appropriation is MANDATED?]

3. Better clarity, simpler path to compliance, and acceptance with no further action on the part of the investigator.

I previewed the site, having just had a paper accepted into a journal that apparently will take care of the upload within 6 months of publication, but I see no reason to spend an extra $700 of scarce and precious taxpayer money to select their "Open Access Option", and in the meantime (nest 8-9 mo), what's the PMCID? Am I supposed to sit around deemed 'non-compliant' even though I am or will be compliant?

Question 2: Yes.

First, honestly consider and implement ways of using PubMed / PMID with autouploads to PMC as a mechanism - the simpler things are, the less the time, and the more transparent (and less high-handed) NIH behaves, the better the compliance will be).

Second, as noted above, monitor whether the NIH-funded investigator’s work becomes publicly accessible (free of charge other than internet access) within a year of publication date (or, in cases when journals use an e-publication date that is earlier than the print date, set the clock going at the ePub date.

Third, minimize the loss of precious $$$ that will be wasted on pig-headed insistence on imperfect, cost-wasteful means of implementing the policy by using accepted principles of statistical sampling (auditing) for purposes of reporting to Congress on the progress each year from 4% compliance (NIH Open Access voluntary) to xy % compliance (Open Access mandatory).

Fourth, during at least the first two years, monitor and ensure compliance in line with principles used for monitoring and accepting compliance with laws such as the speed limit on interstate highways (speed kills, short-term shortfalls in public access do not).

If the NIH and Congress are really serious about enhancing research, and making taxpayer $$$ be used in the most effective ways possible, it should direct its effort more toward effective enforcement of the mandate that unique reagents (mouse lines, plasmids, etc) be shared in a timely and effective manner, in line with written investigator assurances that they will do so [and, for that matter, better screening for overlap in funding between R01’s and PPG’s, etc] than toward the flawed NIH choice of system for achieving Open Access.

Question 3: 1. Honest Information on

a. how much the chosen mechanism will cost to implement (as opposed to incorporation of alternative approaches), including not just the servers and the I.T. support but also the direct and indirect costs charged in the cases where desirable journals (e.g., those that impress grant reviewers) start charging several thousand $$$ for the alternative of having author own copyright – see testimony already logged in response to this RFI) AND a reasonable estimate of the increases in page charges that publishers inevitably will start charging to defray the shift in revenue away from subscriptions – extra page charges that will be shouldered by NIH funds and subtract from the real goals, which are getting and disseminating new data and insights, followed by flow of those insights into better health.

b. how many aggregate NIH $$$ will be spent to cover the direct and indirect cost component of having this dumped on investigators and covered as a direct cost to the grant (as opposed inclusion of an automated system at NIH that is based on PI’s submitting PMID and an NLM computer program pulling the open access text in instances where it was already available, and simply requiring that the PMID be submitted between time of publication and 12 mo thereafter) (number of papers per year x $75 / hr (a low-end estimate of direct + indirect cost of PI time) x at least 60 min / paper -- US government estimates of how little time things take are always ludicrously on low side because of legal mandate that policies be cost-effective; uploading takes longer than 15 min, and then there’s the follow-up emails, the inevitable screw-ups of conversions, etc) [10,000 papers per year would mean at least 2 R01’s gone, which these days means 2 scientists gone; probably 4 gone is more realistic as, after queries and re-edits, this may take 2 hr per paper on average]

c. how many R01’s of average size will not be funded per year because of this form of implementation and construction of PMC (after y’all presumably asked Congress specifically to name PMC as the mechanism for achieving the goal of allowing public to view the fruits of research they funded)?

2. Send an email to all NIH grantees with each of the information links embedded in text, and with each of the instruction presentations attached (slide show on public access policy, 15 slides; NIHMS System Slide Show).

Question 4: In implementation, it is unfortunate and has major unacknowledged costs that were avoidable and, at a time when each decrease of 1 R01 is spelling one less trained scientist as PI in the system, highly regrettable. Probably also is one of those instances where there are two conflicting laws (mandatory review for cost-benefit analysis e.g., in selection of implementation method versus weird set-aside specification of PMC in Sec 218 od PL 110-161) and the whole mess will end up in court – costing further money and undercutting optimal implementation of the general goal.

Among hidden costs – 1. more NIH-funded scientists just saying ‘screw it’ (international competition for scientists) 2. one more bit of bureaucratic creep and reason to advise talented young folks to steer clear of scientific career 3. probably large amounts of money diverted away from actually doing science. 4. Top-quality peer-review (and other aspects of NIH) depend on mutuality with the PI community, and constantly dumping on us or taking such high-handed approaches is not likely to foster the spirit that enhances other NIH needs. And more . .. .

that said, if it were implemented better A reasonable general notion – that the taxpaying public (and congressional staff, etc) should, within a reasonable period of time, have access to articles representing the fruits of the support. A reasonable general notion, that building access with some database characteristics might help NIH get a better handle on its own portfolio and help its program and scientific review officers a bit.

Question 1: Consideration needs to be given to retroactive open access for already-published documents, rather than just new documents. Oherwise, complete databases of full-text will never be openly available, severly limiting the use of the available full-text.

The issue here is comprehensiveness: If even a small portion of the full-text data is missing, users must fear missing something during literature searches, and are therefore pushed to use fee-based options rather than free ones.

05/01/2008 at 10:59:25 AM

Sweet

Douglas

PhD

VCU

Richmond

VA

USA

NIH-funded Investigator

Question 1: N/A

Question 2: N/A

Question 3: When I sign onto PubMed all of my articles appear and have a PMID# - is this compliance?

I can not find out what a "PMCID" number [NIH info] is versus the "PMID" I see associated with my articles in PubMed - is there a difference?

Question 4: N/A

04/30/2008 at 03:49:03 PM

Lackner

andrew

DVM, PhD

Tulane University

Covington

LA

USA

NIH-funded Investigator

Question 1: It makes little sense to go after individual NIH funded investigators for this. You should work with the journals to get this information. This represents a significant additional burden on investigators.

It makes little sense to require accepted manuscripts to be posted if it does not come through the journal. You are going to end up with someone submitting a manuscript as submitted that isn't and then this will get used as an example of how scientists can not be trusted.

Question 2: NIH should rely more on the journals to have the materials submitted and strongly discourage people from submitting to journals that don't follow the policy.

Question 3: If NIH is not going to address this with the directly with the journals then they should provide additional funding to the institutions of all NIH Funded grantees to hire the legal staff to deal with the problem.

Question 4: A wonderful idea in concept but a disaster in implementation. The investigators are not the problem.

04/30/2008 at 02:59:24 PM

MacLennan

John

PhD

University of Cincinnati

Cincinnati

OH

USA

NIH-funded Investigator

Question 1: NIH should go after the journals directly if they really think this is worth it and settle it.

Question 2: No

Question 3: An NIH office should do the screening and posting themselves instead of NIH paying PI time to very inefficiently do it. In terms of research bang for the NIH buck the current system does not seem the best.

Question 4: I am now in the situation of having to either dump a paper that just got accepted after revisions and start all over with another journal (at clearly a cost of $1000s) or pay $2600 of NIH funds to make it available to everyone even though essentially everyone who will read the paper already will have access to it through their institutions. I can not believe this policy is a good use of the very limited NIH funds.

04/29/2008 at 11:22:32 AM

Slater

Michael

Ph.D.

Ohio State University

Columbus

OH

USA

NIH-funded Investigator

Question 1: Yes. The April 7 date for all accepted ms. potentially puts investigators in an extremely awkward position, if an article is currently in the review and revision process--which can take over a year and represent many dozens of hours of work in revisions--and the journal at which it is in review does not currently have a copyright policy permitting posting of a public access version of the article. The investigator either must withdraw the article, losing perhaps a year or more in the publication cycle process; continue forward, hoping that the journal will revise their policy by the time publication is scheduled and, if not, violate copyright in order to avoid violating federal regulation. Had the date applied to all ms submitted by April 7 instead of accepted, investigators would have at least had the option of seeking out journals that had already announced compliance mechanisms or revisions to their copyright agreements, avoiding this dilemna. Some provision for cases such as these (under review but not accepted as of 7 April, and evidence of refusal by the publisher to provide copyright release) would be reasonable, it seems to me!

04/29/2008 at 10:57:32 AM

Vogt

Brent

Ph.D.

SUNY Upstate Medical University

Manlius

NY

USA

NIH-funded Investigator

Question 4: The journal publication mechanism is well established and this NIH process is redundant and unnecessary. What the government has managed to accomplish is to generate a new level of detail and compliance that is not necessary; a process that removes resources from performing research. Once again we have been given a mandate that will do nothing to improve communication but it will remove the funds we need to get our work done. Since this is a mandate, we need to develop a way to reverse the mandate rather than come up with a method for wasting precious resources.

04/28/2008 at 11:52:47 PM

Cutter

Gary

PhD

University of Alabama

Birmingham

AL

USA

NIH-funded Investigator

Question 1: IF NIH wants to mandate this policy, why unload another round of burdens on investigators? This leaves each investigator to negotiate with each journal and a paper by paper basis. This one sided coin, you can only fail is not cost effective. Currently we sign conflict of interest forms, copywrite transfers and the giving of intellectual property to a journal for sale along with all types of additional burdens on investigators without reciprocity. If the journal doesn't make the citation available or an investigator isn't saavy enough to understand copywrite violations and sign the wrong agreement, you are just setting someone up for failure, violations and problems. If this is so important and a legal requirement, and in spirit it is a good idea, why not simply state that NIH will not allow any investigator using public funds for their research to publish in any journal that does not adhere to this policy. One statement and the journal will comply saving thousands of dollars in compliance monitoring. The journals will comply or not have material to publish and compliance will no longer be an issue. Why seek to make criminals of already burdent scientists with threats of legal violations when you could make the norm happen?

These are incredible wastes of the greatest resources this country has, our human capital, as is increasingly common with the enormous amount of NIH mandates. The collective hours of cost is not really worth the repetition of the same effort. You have the power to make this happen and dumping the task on individuals is just setting up people for failure. Where is the thinking about translational science?

Question 2: Yes, NIH take a stand, state the policy and boycott journals that do not adhere to this principal.

Question 3: If NIH is unwilling to strongly negotiate with journals on behalf of the scientific community, it should provide a cadre of legal staff to review each and every nuance a journal could provide in order to capitalize on the intellectual property it now takes to publish in their journal.

04/28/2008 at 10:39:13 PM

Lustig

Arthur

PhD

Tulane University

New Orleans

LA

USA

NIH-funded Investigator

Question 1: I just published in Chromosoma, a journal that gives you two alternatives. Pay 3000.00 to keep the copyright and have open transfer or pay no cost and allow viewing only for those to pay. Other journals have similar policies that are inconsistent with NIH policy. What action should I take?

04/28/2008 at 07:47:20 PM

Roepe

Paul

PhD

Georgetown University

Washington

DC

USA

NIH-funded Investigator

Question 1: I don't have a recommendation for alternative implementation, but I do not understand why publications from key scientific societies (such as American Chemical Society) are apparently not participating in automatic deposit, preferring instead to burden investigators. We pay dues to these societies, perform enormous pro bono peer review for their journals, etc. and they cannot work with NIH to find a fast and efficient way to do this automatically ? What gives ? Even more troubling, some journals appear to be charging fees to unknowing or confused investigators (up to a ridiculous one thousand dollars to satisfy pubic posting requirements). That is just disgusting, the community (and NIH) should be responding strongly to such practices.

It is also ambiguous. You seem to equate "peer reviewed publication" with "journal article". This is wrong, since in some fields funded by NIH peer-reviewed conferences have equal or higher prestige and impact. If you mean "journal", say "journal". IF you mean something else, you need to say that.

There is often no feasible way for an investigator to force compliance with a journal that does not routinely (and almost exclusively) publish NIH-funded research. First off, the relevant person to contact is not routinely and easily available. Second, the delay involved may cause publication deadlines to be missed. The situation with conferences is even worse.

The net effect is likely to be to DETER publication, thus delaying or even preventing dissemination of NIH-funded research results.

Question 2: See above.

It would help immensely if NIH can pro-actively enter into agreements with the major engineering and medical societies. Within engineering, key would include IEEE (publishes many biomed engineering, medical imaging, and other pertinent journals), ASME, MICCAI, CARS/CAS. There are any number of medical societies as well.

You should delay enforcement of this rule until these agreements are in place.

Question 3: Much greater clarification of what is covered and how to go about it.

Some description of what efforts NIH staff are taking to ease implementation of this policy. E.g., see answer to question #2. You might say whom you are approaching and give a contact email address for investigators to query status or suggest additional journals or societies to contact.

Question 4: This is a good idea, but will be a nightmare for investigators unless much more groundwork is laid before it is enforced.

04/28/2008 at 03:55:37 PM

Emery

David

PhD

University of Washington

Seattle

WA

USA

NIH-funded Investigator

Question 1: As currently implemented, this constitutes a significant new burden on NIH investigators, a burden that is unfunded. The NIH's public access policy should be enacted at the level of the NIH, using NIH funds. All papers of consequence are cited on PubMed - why then couldn't the PubMed infrastructure be used to transfer NIH-funded publications to the public domain? Investigators should be able to list their publications as always, and the NIH should shoulder the responsibility thereafter. It is hard enough to get our work published - why is the NIH putting up yet another hurdle?

Question 2: See answer to Question 1 above. The NIH should take the responsibility of implementing the public access policy, not individual investigators.

Question 3: The issue is not one of training, but one of unfunded mandates. The NIH should take the responsibility of implementing the public access policy, not individual investigators.

Question 4: It is a good policy in principle. However, the NIH needs to appreciate the significant burden this places on investigators. The NIH should take the responsibility of implementing the public access policy, not individual investigators.

04/28/2008 at 03:38:43 PM

Means

Michael

President, Health First

Rockledge

Florida

USA

Other Member of the Public

Question 1: I have received the following email notice from you four times. Please stop sending repeatedly.

>>>April 28, 2008

Dear Members of the NIH Research Community:

I am writing to remind you that the mandatory NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html) applies to final peer-reviewed manuscripts accepted for publication on or after April 7, 2008. Making published research funded by NIH accessible to everyone, including health care providers, patients, educators and scientists, helps advance science and improve human health. We all have a role to play in achieving this goal, and I appreciate your efforts to make the NIH Public Access Policy successful.

The NIH Public Access Policy implements Division G, Title II, Section 218 of PL 110-161 (see http://publicaccess.nih.gov/policy.htm), which was signed into law late last year. Compliance with this Policy is a legal requirement and a term and condition for all active grants and contracts awarded as of April 7, 2008. Failure to comply may trigger one or more enforcement actions, depending on the severity and duration of the non-compliance.

Please see the Public Access Web site for the tools you need to comply with the Policy. The Web site houses Frequently Asked Questions (FAQs), training information, and other resources.

To ensure compliance with the Policy, please remember to:

Address Copyright - Make sure that any copyright transfer or other publication agreements allow your paper to be submitted to NIH in accordance with the Policy.

Submit Papers upon Acceptance for Publication

1. Some journals will submit the final published article on your behalf, without your involvement. See http://publicaccess.nih.gov/submit_process_journals.htm for a list of these journals.

2. For any journal other than those on this list, please:

a. When submitting a paper for publication, inform the journal that the final peer-reviewed manuscript is subject to the NIH Public Access Policy.

b. Make sure that any copyright transfer or other publication agreement allows the final peer-reviewed manuscript to be submitted to NIH in accordance with the Policy. For more information, see the FAQ Whose approval do I need to submit my article to PubMed Central? and consult with your Institution.

c. Submit the final peer-reviewed manuscript to NIH upon acceptance for publication at http://www.nihms.nih.gov/. See the Submission Process for more information.

Cite Papers

§ When citing your NIH-funded papers in NIH applications, proposals or progress reports, please include the PubMed Central reference number (PMCID) for each paper.

§ NIH will monitor compliance through citations. Effective May 25, 2008, when your NIH Program Officer reviews your progress report or application, he or she will be expecting a PMCID in the citation of every applicable paper that arose out of your NIH funding, or a manuscript submission system reference number (NIHMSID) if the PMCID has not been issued. See Section C of our FAQ for examples.

§ If you publish through a journal listed under http://publicaccess.nih.gov/submit_process_journals.htm, there might be a slight delay in assignment of a PMCID. That is okay. We have signed agreements with these journals that allow NIH to resolve submission with them without your involvement. To facilitate your Program Officer’s job, we ask that you indicate ‘PMC Journal- In Process’ until the PMCID is available.

The NIH Public Access Policy is a legal requirement and represents an important opportunity for science and medicine. We are very interested in your feedback on the Policy and are soliciting input through a request for information from March 31, 2008 to May 31, 2008. Please send any comments or suggestions to http://publicaccess.nih.gov/comments.htm.

Sincerely,

Norka Ruiz Bravo, PhD NIH Deputy Director for Extramural Research

For the latest in NIH grants policies and initiatives, subscribe to the NIH Extramural Nexus

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04/28/2008 at 03:33:56 PM

Lawton

Teri

PhD

Perception Dynamics Institute

Del Mar

CA

USA

NIH-funded Investigator

Question 1: You have made an NIH policy that is already out of date if you are referring to easy access to published work, since most scientists post their publications on their website.

You now have created such a tedious, laborious process for publication that I will never submit a grant proposal to NIH again. You have ascertained that original, creative, productive ideas such as pathtoreading.com are funded elsewhere.

04/28/2008 at 03:19:38 PM

Brash

Douglas

PhD

Yale School of Medicine

New Haven

CT

USA

NIH-funded Investigator

Question 1: no

Question 2: no

Question 3: no

Question 4: My institution tells us that we must now include the PMC ID number of papers from OTHER laboratories when we cite these papers in our grant proposal or report. But on the NIH website, I only see rules about adding PMC numbers to citations of our own papers. Which is correct? Thanks

04/28/2008 at 03:19:30 PM

caplan

steve

PhD

University of Nebraska Medical Center

omaha

ne

USA

NIH-funded Investigator

Question 1: While I think that the overall idea of freely disseminating inormation from the scientific journals has merit, if the currentsytem is employed, I firmly believe that this idea will turn into a nightmare for the scientific community at large. My comments are based on my experience with PubMed Central, in being asked to submit one of my papers to this forum. While the submission process itself was not particularly difficult, the problem lay in the reformatting of my manuscript that was done to meet the criteria ofPubMed Central. I do not know how my manuscript was typeset, but it was sent to me to "proof' with a tremendous number of errors. I spent an enormous amount of time correcting and proofreading figure legends that were altered- probably 3 entire days worth of work to do so. I did not hear from PubMed Central for another 2-3 months, and then was sent the 'revised' proofs. In beginning to go through these, I could see that 80% of my time consuming corrections were either incorrectly implemented, or not at all. It took another 2 days of work to resubmit this and wait another 2 months for an additional round of corrections. In short, if this system is now mandatory and will be in effect for every paper, I may end up as a researcher spending more time revising and correcting ALREADY PUBLISHED PAPERS than doing anything else.

My suggestion to overcome this would be the publishing of a PDF formatted manuscript supplied by the author(s). If PubMed Central would like to make these 'uniform', perhaps simply making a uniform title page would suffice. The submission of a PDF document by the author would ensure that no typesetting errors/changes will detract from the manuscript, and obliviate the need for the 'proofing' and revisions stages.

04/28/2008 at 02:46:45 PM

Sattler

Alison

University of Washington School of Medicine

Seattle

WA

USA

Other

Question 3: I support several faculty members who need to add PMCID numbers to PUBLISHED works for their progress reports that are due in June. I know how to enter manuscripts into the PubMedCentral database, but not published works. Currently, no information exists for how to add published articles and the journals these were published in aren't included in your list of journals that automatically submit artiles to you upon acceptance.

What do you recommend? How can we comply with the law for adding the PMCID # to articles in grants that were published after April if we don't have a PMCID for the article and can't add it to the system to get a number?

04/27/2008 at 11:58:10 PM

Burack

Jeffrey

J.D.

n/a

New York

NY

USA

Other Member of the Public

Question 1: 1) Reduce the embargo time to the shortest possible period. 12 months is too long. If necessary, implement an modest access fee, shared with publishers, which decreases with the age of the article, becoming zero at, say, six months after publication.

2) Find some way to establish greater access to NIH-funded articles that pre-date the April 8, 2008 policy.

Question 2: Create an easy-to-use form/link that allows members of the public to easily and anonymously report access violations. For instance: "report an access violation," or "Having trouble gaining access?"

Question 4: Great policy advance. Long overdue.

04/24/2008 at 07:45:43 PM

Thiagarajan

Balasubramanian

Ph.D

Annamalai University

Annamalainagar

Tamil Nadu

India

Other

Question 1: No

Question 2: No

Question 3: Nothing more

Question 4: It is a boon to researchers in developing countries like India who can not simply afford to access subscribed journals.

04/22/2008 at 04:13:56 PM

Tooey

M.J.

MLS

Health Sciences and Human Services Library, University of Maryland, Baltimore

Baltimore

Maryland

USA

Representative NIH Funding Recipient Organization

Question 2: One recommendation that I have heard from UMB's research office and from colleagues is that we would like to see a procedure where a notification is sent to the campus office of research when an article from that campus relating to research has been deposited into PubMedCentral. This would close the loop and involve the office of research more closely since the grants and contracts belong to the university, not the p.i. They would be made aware of the PMC ID and could reference it for future communication and tracking.

Question 1: I have a number of recommendations. If they are not presented in a useful format, please let me know and I will modify them. …………………………………………………………………………………………………………….. 1) I strongly support the NIH policy requiring that all peer-reviewed manuscripts arising from NIH funds be submitted to PubMed Central upon acceptance for publication. 2) I am encouraged by the recently passed law requiring that, beginning May 2, 2008,full-text versions of journal articles describing NIH-funded research be provided free via the internet to the public. For two reasons, however, I believe there should be NO DELAY in providing articles online after they have been reviewed and approved in final form. I can imagine only two reasons for delaying access: (1) compensation of publishers for revenue lost from reduced sale of print versions of journals, and (2) preservation of the privileges that prestigious journals and the prestigious contributing authors and institutions now enjoy because of the high quality of their personnel and research, and their ability to pay the high costs required to maintain extensive, up-to-date collections of print journals. In my opinion, it makes no sense to provide everyone in the world with free, searchable access to abstracts of the world’s literature, but, for those unable to pay, delay access to full-text versions of individual articles, and permanently deny the opportunity to browse whole journal issues. The benefits to the whole world of providing free total access are obvious: (1) The costs of providing it to millions of people may be little more than those of providing it to the elite because the digitized copy of every article is already available and instantly transmissible to any number of recipients, from one location (PubMed Central). (2) The process would be further simplified by standardized online entry of individual requests (as is already done), and automated online transmission of recurring requests for specific journals sent monthly to lists of libraries and laboratories (as presumable is already done, and updated regularly). (3) The internet already provides tutorials and academic lessons on many scientific topics. These could be better accessed if managed by or linked to PudMed Central. (4) The reason for not delaying free access is to provide individuals and institutions unable to purchase it (e.g., students and almost everyone in the third world) the same access as the more privileged. The technology required for rapid and affordable dissemination of knowledge throughout the world is now available and in place. It should be embraced without delay, hopefully with the full cooperation of publishers. 3) It seems to me that the process required for the production of pure on-line journals is identical to that required for the online versions of print journals. PubMed Central is able to provide up-to-date online access to full text versions of all biomedical journal articles. It may be time to seriously consider a total transition to print-free journals. I have read arguments for preserving the traditional publishing infrastructure, i.e., the paper printing equipment and professional printers involved in scientific/biomedical publishing. I honestly don’t think that any arguments against electronic publishing and universal free access can hold up against an internet-based system for submitting, reviewing and publishing manuscripts; for providing a forum for public and private comments, questions, debate, and establishment of contacts; and for permanently archiving these publications linked to such feedback. One of the early criticisms of electronic publishing was that the quality of printed photographs, figures and text would be superior. We all know now that that is no longer the case, due to technological advances in digital scanning, electronic display and personal printers. 4) Practical reasons for converting entirely to online production and distribution of biomedical journal articles: (1) Expense: (a) The print journal industry already produces electronic versions, starting with the interactions between publishers, authors, reviewers and editors, and thereafter with NIH, PubMed Central, research institutions and libraries throughout world, and anyone in the world with internet access and the ability to pay. (b) Print versions are very expensive to produce and distribute. It appears that they may soon become a luxury of well-heeled customers, assuming that even that market will remain viable. The print industry has undergone many technological changes. The technologies now available, however, may prove to be the most revolutionary and the most favorable for everyone, including publishers. It is possible that the number and quality of scientists involved in electronic-only publishing would be the same as those now involved in the combined paper-electronic publishing. Possibly the same people would continue to do the work. Academic editors, who are often senior professors, work very hard and are proud to do this important job. I and many of my peers have similarly considered it an honor to serve voluntarily as reviewers throughout much of our careers. All of these factors taken together indicate that the current production of print articles could be duplicated by purely electronic publishing, but without the tremendous time and costs required for the conversion of electronic manuscripts to paper and the mailing of journals. (c) For those who feel the need to have a physical copy in their hands, high quality personal printers are becoming universally available. In the not too distant future, electronic-paper hybrids may end up becoming the standard tools for downloading and viewing scientific and other literature. At this moment, such alternatives to traditional books are proliferating, competing with each other, and winning converts. (d) Communication satellites may represent a practical and affordable means of providing information to the most isolated areas of the world. These areas have the greatest need for medical information, and for other information consistent with local regulations and customs. Summary: I think that the importance and economics of providing universal access to biomedical literature and professional contacts far outweigh those of any other alternatives, and that there should be no delay or compromise in providing this access. The costs of providing internet access throughout the world would be dwarfed by the costs of maintaining the print journal industry. The following examples emphasize the urgency of this need. (1) Many talented people from poor countries obtain advanced degrees from western medical schools, but upon return to their home communities are unable to solve many medical problems they face. Many of the most talented of these people remain in or return to advanced countries. For such people, state of the art facilities for keeping up to date and discovering important contacts would provide an essential lifeline and incentive to stay in their home countries. (2) During a six year period I spent doing research and providing training in Egypt, a country with eleven medical schools, three of which are in Cairo, there was very little access to current medical literature. (3) The situation is much worse in parts of the world that are now facing catastrophic epidemics and other medical problems. It is only through the efforts of Doctors Without Borders and other volunteer organizations that some communities are surviving at all. Enabling local doctors to obtain up-to-date information, and to share data and publish jointly with contacts elsewhere, would save many lives and revolutionize third-world medical education.

04/15/2008 at 01:14:45 PM

Myers

Gary

MD

University of Rochester Medical Center

Rochester

NY

USA

NIH-funded Investigator

Question 1: It is reasonable to require that NIH investigators submit a pdf of any published manuscripts that result from NIH funding. It is not reasonable to require each individual investigator to place them in the public domain. In essence this means that thousands of investigators must divert valuable resources and time to learning the system. It would be more reasonable to have an office at NIH that is responsible for obtaining the PubMed number and placing them in the public domain, a process that requires learning the copyright restrictions of thousands of journals.

Question 2: A simple search of the literature by a central office on each investigators name would determine compliance and then reminders could be sent.

Question 4: The public access of these manuscripts is desirable, but requiring thousands of investigators to learn new procedures and invest large amounts of time is not cost efficient.

Question 3: BioOne (www.bioone.org) has recently released a model publication agreement that addresses current trends in copyright assignment and requirements by NIH and other funding agencies for digital repository deposits. While the Agreement was developed at the request of several BioOne publishers, it may be of interest to any scholarly publishing organization that is seeking a clear, concise, and legally vetted publication agreement.

In March 2007, the legal firm Morrison & Foerster LLC (www.mofo.com) generously agreed to provide pro bono legal assistance to BioOne in drafting a Model Publication Agreement. Ms. Pamela Pasti, Of Counsel in the Technology Transactions Group of Morrison & Foerster’s San Francisco office, was assigned to the project. Over the course of the following year, Ms. Pasti worked with BioOne to review existing publication agreements, notable author’s addenda, and articles describing emerging trends in copyright law as it relates to academic publishing.

The resulting agreement allows author(s) to retain copyright, while granting the publisher both a temporally limited and exclusive right to first publish, and a perpetual, non-exclusive right to publish, distribute, and sublicense. In response to NIH’s Public Access Policy (passed by Congress in December 2007) and other institutional and subject repository deposit mandates, the Agreement allows authors to deposit their work in digital repositories directly, or permits the publisher to deposit to the National Library of Medicine on their behalf.

The BioOne Model Author Agreement reflects over a year of work for all involved in this important project. From the onset, we felt strongly that BioOne was in a unique position as a collaborative publishing endeavor to draft an equitable agreement, which would not have been possible without the legal guidance of Morrison & Foerster, and the invaluable feedback garnered from the publisher and library community.

The final Agreement is freely available on the BioOne website at www.bioone.org. An accompanying “roadmap” is also available to provide publishers adopting the Agreement with guidance on specific author and publisher rights and amendable sections.

Question 1: This (uploading the pdf file of accepted manuscripts) should be done when we file our annual progress report in the commons. It is redundant to have to send the pubmed ID in the progress report and then upload the pdf file via another website.

Question 2: Compliance is going to be poor since the current help on the NIH website is confusing for even the most computer savvy person. Compliance could be improved if the uploading process was included in the eSNAP portion of the progress report.

Question 3: The term electronic version is very vague. Do you mean the final pdf version that the journal publishes. Alternatively, you could imagine submitting the word document and figures as a pdf that is not formatted by the journal. This version would probably not be covered under the copywrite laws, but then again as a PI, I really have no idea. I think clear, concise language needs to be used to inform the PI's of how to deal with publications that are not open access.

Question 4: The issue of copywrite infringement with the ACS (american chemical society) journals is an issue. Do we just upload the pdf file to the NIH even if it is not publically avialable. The FAQ is totally vague and recommends that the PIs contact the journal. This is ridiculous. The journal will tell us that we can't do it because they want to make money and not have the paper freely available.

04/09/2008 at 01:44:35 PM

Cohen

Zohara

PhD

National Institute of Biomedical Imaging and Bioengineering / NIH

Bethesda

MD

USA

Other

Question 3: I understand that the current policy does not cover non-peer-reviewed conference papers. The policy is not clear regarding peer-reviewed conference papers. Please make sure this is clear in the final version.

04/09/2008 at 10:08:59 AM

Shera

Christopher

PhD

Harvard Medical School

Boston

MA

USA

NIH-funded Investigator

Question 1: NIH should not reformat, repackage, retypeset, or otherwise corrupt pdfs provided by the author or journal. Reformatting wastes time and resources and introduces substantial errors. To maintain the integrity of the science, and the value of the repository, manuscripts should be posted exactly as received from the author or journal.

04/04/2008 at 03:36:56 PM

Resnick

Rachelq

MS

Abramson Ctr. for Jewish Life/Polisher Research Inst.

North Wales

PA

USA

Other

Question 1: If a publisher provides public access to an article within 12 months of publication on its own website, allow that to be an acceptable form of publication, as long as they also provide a link to the free, full-text from PubMed and PubMed Central. If a publisher should go out of business or transfer management of a journal to another publisher, mandate that the publisher upload all relevant articles into PMC before the changeover.

Question 2: Follow up with grantees each year up to three years after the end of a project to request the citations and PMCID numbers of the articles that have resulted from the research. If none are provided after three years, bar all of the relevant grantee investigators' organizations from receiving further funding until they are in compliance.

Question 3: How long does it take between the time the manuscript and related files are uploaded, and the PI is asked to approve the final version?

Is the version of record going to be the PMCID HTML file, the PMCID PDF version, or the publisher's version? Will having three versions out there affect the way authors cite the resources within their papers?

If, after an article is published on PMC or in a journal, a mistake is found, how are corrections (or retractions) handled?

Question 4: As a librarian, I thank you for making this mandatory.

04/04/2008 at 02:24:06 PM

Reinhard

Robert

M.A.

Member Community Advisory Board, ACTG and HVTN within NIH

San Francisco

CA

USA

Patient or Representative of a Public Health Advocacy Organization

Question 1: NIH can provide overhead and funding support in its grants to allow investigators to use the option many journals provide to subsidize immediate open access publication of specific articles. However, NIH can make this option much more cost effective if it uses its negotiating power to secure reduced rates for funded authors from journals who use this option. The current costs of these options are not based solely on true publishing costs alone; they may include premiums to subsidize other profit interests unrelated to publication, there is no rationale a subsidized payment should pay for the externatlities. This procedure would mitigate concerns of journals, benefit the public and accelerate deposit in pubmed central. Also the policy shouod be revised to require deposit no later than 6 months or as soon as possible rather than the 12 month rule

Question 2: In any future grant applications, the application form or electronic submittal should include a field requiring citation to all previoulsy required pubmed central deposits, failure to cite would be considered reason to return the application as incomplete

04/04/2008 at 01:08:51 PM

Boyden

Edward

Ph.D.

MIT

Cambridge

MA

USA

NIH-funded Investigator

Question 1: The current policy is going to be very difficult, if not impossible, for investigators to achieve. Individuals have far less bargaining power with journals than the NIH would. To place the burden of securing copyright, etc. on the individual is a big burden. If the NIH could work directly with journals, compliance would be possible.

04/04/2008 at 11:25:28 AM

sanders

pat

ged

na

bennington

nh

USA

Other Member of the Public

Question 1: no

Question 2: no

Question 3: depression

Question 4: no

04/04/2008 at 11:25:23 AM

sanders

pat

ged

na

bennington

nh

USA

Other Member of the Public

Question 1: no

Question 2: no

Question 3: depression

Question 4: no

04/04/2008 at 10:25:41 AM

Buchwald

Stephen

Ph.D.

MIT Department of Chemistry

Cambridge

MA

United States

NIH-funded Investigator

Question 1: Require the publishers to submit the manuscript, as many have voluntarily agreed to do, to PubMed. Placing the burden on the P.I.'s will further take away from valuable research time.

Question 2: Although at first blush it sounds like a bad idea, requiring publishers to do this in order to submission to their journals will quickly get everyone to go along with my suggestion in question 1.

Question 3: Having an automated way to do this would be helpful. Going about it in a piecemeal way invites chaos. Also, I can imagine trying to submit a proposal without the required information. There needs to be some way to handle cases where computer or other issues come up unexpectedly.

Question 4: Was the intent of the law really to do this or was it really

04/04/2008 at 05:27:23 AM

Salamon

Peter

PhD

San Diego State University

San Diego

CA

USA

Other Member of the Public

Question 1: No.

Question 2: No.

Question 3: Don't know.

Question 4: I think that the policy is a great step forward!

04/03/2008 at 04:37:20 PM

Williamson

Peter

MD/PhD

Univ IL at Chicago

Chicago

IL

USA

NIH-funded Investigator

Question 1: The stated policy will serve to transfer costs from university library budgets to the investigator. The NIH will need to reimburse investigators for this increased costs, either thorough commensorate reductions in indirect costs or by direct funding of publication lines in budgets.

Question 2: Providing funding by NIH for the increased burden of this regulation to the investigator would serve to improve compliance.

04/03/2008 at 02:32:40 PM

Watson

Cheryl

PhD

University of Texas Medical Branch

Galveston

TX

USA

NIH-funded Investigator

Question 1: I think that all withholding of government-supported published information from the public is unacceptable. This puts up unnecessary roadblocks of many kinds to every scientist and member of the public who would like to make use of this information. By having delayed revealing of the published information after several months to a year, you are creating an extra burden on scientists and their staff to manage this process. This is a lot extra work for something that is completely unnecessary.

Question 2: Keep it simple. Require that all publications be made available immediately. Then you will not have to manage it in such a complicated way.

Question 3: I would like it to be such a simple system that no one requires any training. Just make the information available as soon as it is published.

Question 4: If it is not possible for commercial publishers to abide by rules of total and immediate disclosure of publically funded studies, then scientists should adopt a completely different system for publishing their papers.

04/02/2008 at 01:59:18 PM

Labuhn

Denis

MD

Einstein

NY

NY

USA

Other Member of the Public

Question 1: Yes. Obviously this undermines copyright laws and by extension patent law and other intellectual property laws. This needs doing in the digital age. Once the idea is out then it belongs to everyone and should be used freely. The one year grace period will ease the transition and destruction of private journals like Cell and Nature. That is OK. They are dinosaurs and need to go along with all intellectual property rights laws. Pharmaceutical companies will be the next to go. There is a problem there because withoug patents they will not be able to recoup their research and development costs. That 3/4 billion dollar FDA regulation will stop new drug discovery and keep them from being brought to US markets. That is OK. The Chinese will do it for us soon anyway. Please please information must be free. No restrictions. Let's destroy our intellectual economic base and get on with the brave new world. China will give us what we need.

Question 2: I would suggest immediate and permanent halt of all funding to the investigator and his institution if they do not comply with this destruction of intellectual property. If Universities do not fight this idiocy then make them pay. They should know better than to go quietly but hey no one at a University understands money anyway. It has always come from the Government and the State, AND always will. Why protect the intellectual property they generate? All that counts is continuing to get NIH funding. So threaten to cut if off and see if they respond. They just might.

Question 3: The idea is simply. If the US government through NIH pays for it then it belongs to them and not the PI or the University so who needs to worry what they think. All that matters is what NIH thinks.

Question 4: Keep stop this nonsense but thanks for asking.

04/01/2008 at 12:53:03 AM

Ammann

Arthur

MD

Univeristy of California

San Rafael

CA

USA

Patient or Representative of a Public Health Advocacy Organization

Question 1: Clarification of the policy is required

I have spoken to many individuals regarding the new policy and it is still not clear if NIH support means any author in a multi-author article or whether all of the authors. Several years ago when one of the NIH funded authors objected to copyright of an article, the New England Journal of medicine removed the author from the article in order to publish and used the other authors.

As I interpret US copyright law, the intent was to protect the public from inappropriate ownership of publicly funded projects which now would include research grant results. Would the policy therefore also include articles written in publications that are not traditional medical journals such as textbooks, educational items supported by promotional companies but which include work performed by NIH funded investigators, PowerPoint presentations at scientific meetings etc. clarification of exactly what this policy covers is critical.

Question 2: you may already have in place a reporting procedure. I review many articles for our web site www.womenchildrenhiv.org - we are frustrated by not being able to provide the full text articles. As you know the abstracts are often inaccurate and often are not supported by the data in the text. It is essential that individuals with limited access to the Internet such as in resource poor countries be provided fulltext PDF articles.if after one year such articles are not available to who would report a violation and would receive a response so that we could go ahead with publication of fulltext articles?

Question 3: see above

Question 4: I am aware that there was a debate as to whether the time limit should be three months, six months or 12 months. The 12 month time period is much too long for information that relates to life-saving information both in the US and especially in resource poor countries. Since carrying out conclusions of articles often requires the entire methodology and the discussion includes cautions and alternatives it is essential that the article and not just the contract be available in a timely manner.

I would argue that the TRIPS agreement is applicable to publication of articles just as it is applicable to patented drugs. It makes no sense that generic drugs can be manufactured in countries one life-threatening health situations exist but the articles which tell us how to use the drugs are still under intellectual property control. As the HIV epidemic moves more and more into resource poor countries, the physicians who perform the studies, the patients who are participants in the study, and the health care professionals who are responsible for health care require that the information be provided to them in a timely manner. A12 month delay is just too long.

04/01/2008 at 11:09:13 PM

DuBose

Terry

MS, RDMS

Univ. Arkansas for Medical Sciences

Little Rock

Arkansas

USA

Representative NIH Funding Recipient Organization

Question 1: NIH and tax payer funded research publications should be available to the public at no charge. This is the best way to promote advances in the sciences.

Question 2: The more widely available the publications, the better.

04/01/2008 at 08:33:01 PM

yu

hong

phd

uw-milwaukee

Milwaukee

WI

USA

NIH-funded Investigator

Question 2: Since PubMed is widely used by biomedical researchers, NIH may demand that an article can only be indexed by PubMed if it is compliant with the PAP.

04/01/2008 at 06:14:25 PM

Snider

Marc

BS Computer Science

citizen

Merrimack

NH

USA

Other Member of the Public

Question 1: I absolutely concur with the proposal that all researchers supported via public funding be mandated to provide their research results for free public access at the NIH pubmed facility. There is no defensible reason as to why mandatory public access to research subsidized by public funds should be precluded.

I also do much research online using the NIH and pubmed facilities. I, too, have also been frustrated by the requirement to purchase research articles published by third party outfits which profit using this publicly funded research as a means to sell their publications. If the public funds the research then the public should have access to the results.

I suggest the following minor modifications to the proposal. 1) mandatory publication of research data at the time of acceptance for publication. If the subsequently published article has changed for any reason then the later published article should also be entered into the pubmed facility. The original submission (prior to publishing) should then be archived at pubmed, thus allowing access to the later published article from the original pubmed submission and vice versa. Such a mechanism would be very useful, I believe, in terms of later auditing for the purpose of establishing how many articles had been changed between the time of research completion/initial-pubmed-submission and the time of journal publication. Such changes of article content may thus shed light later on any differences between the two articles and help to establish a historical chain of information which may prove useful for several different reasons. The more transparency the better...

In the event an article changes between the time of original pubmed submission (publication acceptance time) then the updated/changed article should be required for submission to pubmed no later than 2 weeks after original article publication (and hopefully even sooner).

Question 2: I suggest that all publications which [ever] publish articles based on research funded by NIH (public) funds be required to inquire the following of all article authors/co-authors:

1.) Was any of the research encompassed by your article funded using NIH or other public funds?

The aforementioned question should be answered in writing by *all* authors/co-authors listed on all published articles along with that author's/co-author's signature.

In the event that any author or co-author answers 'yes' to the question then the publication (publishing entity) should then be required to submit a copy of that paperwork to the NIH (or pubmed facility). In the event an author/co-author answers the question untruthfully then sanctions should be applied that individual. In the event the document is not properly procured by the publishing entity and/or not submitted to NIH (or pubmed) prior to publication then the sanctions should be attendant upon the publishing entity.

It should also be mandatory for all authors having answered 'yes' to the question to retain a copy of the signed disclosure form so as to indemnify themselves against sanction in such cases as the publishing entity neglected to submit the disclosure form to the NIH.

Question 3: Nothing really. The public access mechanism provided by pubmed is truly one of the shining lights of the federal government (which too often otherwise does not act in the real public interest).

Ensuring timely and unfettered public access to research data supported by public funds is an extremely valuable and laudable pursuit.

04/01/2008 at 04:45:44 PM

Murphy-Ullrich

Joanne

PhD

UAB

Birmingham

AL

USA

NIH-funded Investigator

Question 1: The requirement to include the PMCID number in NIH applications is an undue burden. This means modifying each investigator's endNote or Ref Manager libraries one by one to include this number. This is going to be time consuming and cumbersome.

04/01/2008 at 04:29:25 PM

Silterra

Jacob

B.S.

None

Cambridge

MA

USA

Other Member of the Public

Question 2: I would recommend that any institution which receives a certain level of funding from NIH be required to notify NIH whenever any research, even non-NIH funded research, is published. They wouldn't need to send the article, or make it publicly available, just notify NIH they published something. This would make sure that NIH could track publications, so they could easily monitor whether works being published privately should also be published publicly.

04/01/2008 at 03:42:50 PM

Cook

Andrew

PhD

Physics

Eugene

OR

USA

Other Member of the Public

Question 1: Research financed by the public should be publicly available on the Internet. Referees aren't paid and they do the lion's share of the work in publishing a paper. If old prestigious journals refuse to make publicly-funded research available, new journals will become more prestigious.

Question 2: Let professionals in the field report on transgressions. Let the NIH without a portion of funds from researchers who don't allow their material to become publicly available.

Question 3: Information regarding the NIH's communication with the NSF on this policy.

Question 4: The public access policy is very important. The National Science Foundation and Department of Energy should follow suit immediately. As a physicist, I often have trouble accessing publicly funded research in a timely manner due to my University's decreased journal budget.

04/01/2008 at 03:38:07 PM

Hulbert II

Leland

None

Gloversville

NY

USA

Other Member of the Public

Question 1: No. I applaud the change to make public funded research more open and accessible to the public.

Question 2: Any applicant for NIH funding can be searched for previous NIH funded projects. These projects would then be checked to verify that their final results exist in the public repository. Any previous publicly funded project that has not been already published in the public archive would bar the applicant from receiving any future funding. This will make the applicants themselves responsible for policing the policy.

04/01/2008 at 02:44:18 PM

Ritchie

Thomas

B.S. of Biology

Rutgers University

New Brunswick

NJ

USA

Other

Question 1: No. I am happy with the changes.

Question 2: Provide a means for the scientific community, even individuals acting independently from their organization, to anonymously report to the NIH any compliance violations. There are enough of us interested in keeping the scientific knowledge gained open and available to the public that this should provide a good level of oversight without much overhead cost.

Question 3: The use of podcasts to go along with powerpoint presentations provides for much better context-specific interpretation of the slides offered. The USPTO provides audio lectures to go along with downloadable slideshows to educate patent practitioners about new USPTO policies and it has been both popular and successful.

Question 4: Allowing public access to full HTML text documents of all research using Federal money is the best change for the advancement of scientific knowledge currently possible. I've been annoyed that it took the PLoS to finally goad the NIH into enacting this policy, but I won't complain so long as I can access research papers that for so long have been inaccessible due to exorbitant fees that I as a student couldn't hope to afford.

04/01/2008 at 02:39:15 PM

Rubin

Ethel

PhD

BioFortis

Columbia

MD

USA

Other Member of the Public

Question 1: I think the final copy of the article is most useful, both for the public and the PI or publisher to post. I do worry about the administrative burden for all PIs, who are already swamped in an ever-increasing regulatory environment. The policy only states that the PI on a grant is ultimately responsible for ensuring the article is submitted. I suspect, like many other admin duties, this too will be delegated to someone else, perhaps rightly so. Suggestions that this become part of an institutions library services might be a solution for overburdened PIs.

Question 2: The only thing for sure is that money talks. If non-compliance carried the penalty of failure or demotion for further rounds of funding, this NIH policy will be a success. Monitoring compliance is difficult. Program managers may need to routinely sweep Pubmed for any of the PIs citation which does not carry the biomed central ID to turn up 'noncompliant papers' before a grant award is made.

A policy without consequences for noncompliance (reward for compliance) is useless.

Question 3: Communicating the policy to patient advocacy groups is very important. Patients have been frustrated for years to have liimited access to journal articles or paying for access to the data they seek.

Question 4: It is about time!

04/01/2008 at 02:09:30 PM

Freytag

Richard

Masters

Freytag & Company, LLC

Reston

VA

USA

Other Member of the Public

Question 1: If publishers continue to pressure against the Public Access Policy then NIH implement a voluntary online peer-review mechanism through the NIH website along with PubMed. Even the threat should quelly publisher resistance.

Question 2: I suggest that NIH require all recipients of funds when publishing their research acknowledge both the NIH funding but the exact PubMed citation(s) (including URLs for the paper(s) on PubMed). The presence of these URLs will make checking compliance very easy. The absence of the citation will also make non-compliance easy to detect.

Question 4: This public access policy is overdue and an excellent policy that I can only hope other national research funding agencies will emulate.

04/01/2008 at 01:58:18 PM

Simpson

S

BS

Self

Boise

ID

USA

Patient or Representative of a Public Health Advocacy Organization

Question 1: I have a rare disoorder. I use pubmed and other online resources to learn about my disorder. I am often frustrated by only being able to access the abstract. Accessing a single full article typically costs in excess of $30 (which is ridiculous).

I'm glad to see the NIH making the publications that they sponsor available freely to the public.

04/01/2008 at 01:50:27 PM

Foster

Ryan

PhD Candidate

University of Florida College of Medicine

Gainesville

FL

USA

NIH-funded Investigator

Question 1: No

Question 2: Ensuring compliance is quite simple really. In grant renewal applications, only allow researchers to cite their own papers from the public access database.

When applying for grant renewals, researchers cite the papers that resulted from the last iteration of that grant. Kind of a track record proving that the grant generated real advances in the field and thereby making a case for continuing to fund that grant. If researchers were compelled to cite only their public access papers they would fall all over themselves to do so.

Question 3: Nothing useful to add.

Question 4: I would be intensely interested in how the NIH funded research has been used to generate treatments and drugs for various diseases. I am especially interested in publicly funded research that has been directly used to generate a patented drug or treatment.

It would be easy to ask NIH funded researchers to provide a brief synopsis of drug developments that immediately stem from their work. 2-3 sentences per paper per year would be sufficient and that blurb could be used to track publicly funded drugs and treatments.

04/01/2008 at 12:46:10 PM

Dante

Doug

Bachelors

Personal

Detroit

MI

USA

Other Member of the Public

Question 1: I would like all NIH funded research to be freely available under the broadest possible copyright, so that anyone may comment, quote, or redistribute that research in any context whatsoever.

Question 2: All NIH funded grants subject to the public access requirement should be available to the public on a web site with information at the time that the grant is made. All grants not subject to that requirement should also be listed and a reason why they can't be given to the public should be included. (e.g. National Security)

Question 3: All NIH funded grants subject to the public access requirement should be available to the public on a web site with information at the time that the grant is made. All grants not subject to that requirement should also be listed and a reason why they can't be given to the public should be included. (e.g. National Security)

Question 4: I would like all NIH funded research to be freely available under the broadest possible copyright, so that anyone may comment, quote, or redistribute that research in any context whatsoever.

All NIH funded grants subject to the public access requirement should be available to the public on a web site with information at the time that the grant is made. All grants not subject to that requirement should also be listed and a reason why they can't be given to the public should be included. (e.g. National Security)

04/01/2008 at 12:18:33 PM

Romans

Ehs

PhD

UT

Arlen

TX

USA

NIH-funded Investigator

Question 1: NOW YOU LISTEN TO ME. PUBLIC TAX PAYER MONEY MEANS YOU NEED TO KEEP THE SYSTEM ___OPEN___

Question 2: `NOW YOU LISTEN TO ME. PUBLIC TAX PAYER MONEY MEANS YOU NEED TO KEEP THE SYSTEM ___OPEN___

Question 3: NOW YOU LISTEN TO ME. PUBLIC TAX PAYER MONEY MEANS YOU NEED TO KEEP THE SYSTEM ___OPEN___

Question 4: NOW YOU LISTEN TO ME. PUBLIC TAX PAYER MONEY MEANS YOU NEED TO KEEP THE SYSTEM ___OPEN___

04/01/2008 at 11:51:59 AM

LaValle

Craig

Prologic Technology Systems

Austin

TX

USA

Other Member of the Public

Question 1: I would like to see all taxpayer funded research, in whole or in part, published and accessible free of charge in the public domain.

Question 4: One of the foundations of science is communication. Open access will allow communication and ideas to flow more freely and stoke the fires of scientific inquiry and progress. It will also help prevent needless duplication of effort. In short, this is a common sense proposal that can only help humanity.

04/01/2008 at 09:28:28 AM

Milgram

Eric

Ph.D.

Individual

Wake Forest

NC

USA

Other Member of the Public

Question 1: No. Clearly, much effort was put into planning the policy and I don't see any obvious problems with it.

Question 2: By making publication on PubMed one of the conditions of receiving a grant, I believe that most people will comply. I recommend clearly stating what penalties a researcher will incur should they not comply with the policy. Also, grants currently are reviewed for progress, and as part of this review process, one of the items should be to check that all peer reviewed publications have been submitted in accordance with the NIH Public Access Policy.

Question 3: At this point, I do not understand how violations of the policy will be handled. Specifically, I read that violations will not affect funding outcomes, and will be dealt with "administratively." I would like to see more detail here. The penalties for not complying should be clearly stated, and should also be of such a nature to serve as a strong deterrent for not complying with the policy.

Question 4: I am very happy that this policy was enacted. Although I recognize the important role that publishers have in the process of disseminating scientific information, I also recognize that without public funding of the research itself, those publishers would have no content.

The internet and the WWW have changed the options for publication tremendously. Understandably, the publishers who have provided a valuable service to the scientific community, while simultaneously building a very successful and profitable business, do not want that to change.

However, just as the digital camera changed the field of photography by making it cheaper and more accessible, the WWW is doing the same thing for publishing. Many successful photographers who had built their business using the constraints of the pre-digital era had a hard time transitioning to the digital era. In this same way, some publishers will not make the transition, but there will be many opportunities for those publishers who embrace the digital age and think innovatively.

04/01/2008 at 08:44:34 AM

Antonuccio

David

Ph.D.

University of Nevada School of Medicine

Reno

NV

USA

Other Member of the Public

Question 1: I think the NIH Public Access Policy is a step in the right direction of fulfilling our obligation of beneficence to the human subjects who volunteer for scientific studies with the hope, promise, and expectation that they will be making a contribution to science and the well-being of other human beings. I would encourage NIH to consider going a step further and requiring that raw human subject data also be made publicly accessible (absent identifying information) so findings from publicly funded studies can be independently analyzed and verified by other scientists (please see rapid response entitled Universal Human Subjects Commitment at http://www.bmj.com/cgi/eletters/336/7643/532 or Researcher's Credo at http://www.bmj.com/cgi/content/extract/336/7645/629). Actually, I believe we owe such access to all human subjects who volunteer for scientific studies, whether they be publicly funded or privately funded. NIH is in a position to set the standard.

03/31/2008 at 06:09:49 PM

Gudas

Lorraine

PhD

Weill Cornell Medical College

New York

New York

USA

NIH-funded Investigator

Question 1: I think that this policy puts one more administrative burden on researchers, who are already being overwhelmed with new mandates, even as the competition for funding becomes greater and greater. My recommendation is that the journals submit these manuscripts for public access 6 months after publication.

Question 2: No, I don't think the policy is wise or necessary.

Question 3: I have no idea.

Question 4: It is not necessary and a waste of time and money. Duplication of time and effort.

03/31/2008 at 02:03:22 PM

Harnad

Stevan

PhD

Universite du Quebec a Montreal & Southampton University

Montreal

Quebec

Canada

Representative NIH Funding Recipient Organization

Question 1: Yes. Modify the procedure for fulfilling the deposit requirement of the NIH self-archiving mandate in order to make it compatible with, and to reinforce, university self-archiving mandates (such as Harvard's):

In the NIH interface, at the point of deposit, add a feature that allows the full-text deposit to be downloaded from the URL where the full-text has already been deposited in the fundee's institution's Institutional Repository (IR).

And stipulate in the overall instructions that the preferred way to fulfill NIH's self-archiving mandate is to deposit the full-text directly in the fundee's IR and then download it to the NIH deposit site.

Question 2: Yes. The optimal way to monitor and ensure compliance is by making it part of the fulfillment conditions for the fundee's institution that it must monitor and ensure that the deposit is made.

The best and easiest way that an institution can monitor and ensure deposit -- and at the same time encourage or mandate the self-archiving of all the rest of the institution's research output in all disciplines (not just NIH-funded research) -- is to require direct deposit in the institution's own IR.

See: "How To Integrate University and Funder Open Access Mandates" http://openaccess.eprints.org/index.php?/archives/369-guid.html

Question 4: The NIH policy is splendid, timely, historic. But it can be made orders of magnitude more successful, effective, and worthy of emulation worldwide if the one small implementational detail I have recommended is adopted.

There will then be a synergy between funder OA self-archiving mandates like NIH's and institutional OA self-archiving mandates like Harvard's, with one point of direct deposit (the institution) and both the institution and NIH jointly monitoring and ensuring compliance.

03/31/2008 at 11:30:31 AM

Hildebrand

John G.

Ph.D.

University of Arizona

Tucson

AZ

USA

NIH-funded Investigator

Question 1: Instead of requiring submission of an article as soon as the manuscript has been accepted for publication, it would be wiser and more palatable to require submission AFTER publication. Articles often undergo final editing when in galley proof, and in fact serious mistakes sometimes are corrected then. It would be best to have the version submitted to PubMed be identical to the version ultimately published.

03/31/2008 at 10:30:28 AM

Burns

Robert

B.A.

Individual

Arlington

VA

USA

Other Member of the Public

Question 1: As an alternative means of implementing the NIH policy, I’d like to suggest allowing publishers to voluntarily enter into a binding memorandum of understanding (MOU) with NIH. Such a voluntary agreement would detail how a publisher would help their NIH-funded authors comply with the new policy (e.g., copyright transfer agreements, submission procedures, etc.). It should enable publishers to submit journal articles on behalf of their authors, control the quality of the articles submitted, and do so in a manner consistent with copyright law. In exchange, however, the publisher would have to assume the NIH-funded investigator’s liability for complying with the agency's public access policy.